Clinical trial NCT04479514
Conditions: Pediatric Cancer CNS Tumor, Childhood Skin Inflammation
Keywords: Pediatric Cancer CNS Tumor, Childhood Skin Inflammation
Sponsor: Dana-Farber Cancer Institute
Start date: 2020-10-01; Completion date: 2025-02-15
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is examining a preventive skin care regimen for children diagnosed with a brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.

Detailed description:
This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care, sun protection and dilute bleach baths might decrease the chances or the severity of skin changes that occur during treatment for brain tumors.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will receive a study treatment regimen that involves a daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.

Participants enrolled in this study, will be in this research study during the course of their anti-cancer treatment and receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer treatment.

Participants will be followed for twelve weeks.

It is expected that about 20 people will take part in this research study.

Arms: arm 1: Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.

Participants will receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of treatment, and at twelve weeks after the start of treatment.
Interventions: intervention 1: Warm Baths or Showers intervention 2: Moisturizer intervention 3: SPF 30 or Higher Suncreen intervention 4: Sun Protective Clothing intervention 5: Limited Sun Exposure intervention 6: Dilute bleach baths
Intervention descriptions: intervention 1: Daily warm baths or showers intervention 2: moisturizers applied daily immediately after bathing intervention 3: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. intervention 4: Sun protective clothing worn when outdoors intervention 5: Limit sun exposure during peak hours of 10am-4pm intervention 6: Warm 10-15 minute dilute bleach baths every other day

Protocol documents:
Prot_SAP_000.pdf: 
DF/HCC Protocol #: 19-579
TITLE: Preventative Skin Care for Children Undergoing Targeted Therapy for CNS and PNS 
Tumors
Coordinating Center:
Dana-Farber Cancer Institute
*Principal Investigator (PI):
Jennifer Huang
Boston Children’s Hospital 
300 Longwood Avenue
Boston, MA 02115
Phone: 617-355-1477
Fax: 617-730-0308
Email: Jennifer.Huang@childrens.harvard.edu
Other Investigators:
Danny Linggonegoro 
Boston Children’s Hospital 
300 Longwood Avenue
Boston, MA 02115
Phone: 857-218-5296
Fax: 617-730-0308
Email: danny.linggonegoro@childrens.harvard.edu
Susan Chi, MD
Dana-Farber Cancer Institute 
450 Brookline Avenue
Boston, MA 02215
Phone: (617) 632-4386
Email: Susan_Chi@dfci.harvard.edu
1


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Statistician:
Wendy London
Boston Children’s Hospital 
300 Longwood Avenue
Telephone: 617-632-4895
Email: wendy.london@childrens.harvard.edu
Protocol Type / Version # / Version Date: Original / Version 3.0 / 7.24.2023


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SCHEMA
Prospective, Single-Arm Trial
Diseases:
CNS or PNS tumor
Skin 
reactions 
to 
Targeted BRAF, MEK or 
pan-RAF
inhibitor 
therapy
Treatments: 
Preventative Skin 
care
routine 
(PSCR) + dilute 
bleach baths
CNS or PNS tumor + 
treatment with 
targeted
BRAF
or 
MEK
Or pan-RAF 
Inhibitor
(8 participants)
Preventative skin 
care routine + dilute 
bleach baths


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TABLE OF CONTENTS
SCHEMA.........................................................................................................................................3
1.
OBJECTIVES......................................................................................................................6
1.1
Study Design............................................................................................................6
2.
BACKGROUND .................................................................................................................7
2.1
Study Disease(s).......................................................................................................7
3.
PARTICIPANT SELECTION...........................................................................................10
3.1
Inclusion Criteria ...................................................................................................10
3.2
Exclusion Criteria ..................................................................................................10
3.3
Inclusion of Children and Minorities.....................................................................10
4.
REGISTRATION AND RANDOMIZATION PROCEDURES.......................................10
4.1
General Guidelines for DF/HCC and DF/PCC Institutions...................................10
4.2
Registration Process for DF/HCC Institutions.......................................................11
5.
TREATMENT PLAN........................................................................................................11
5.1
Pre-Treatment Criteria ...........................................................................................12
5.2
General Concomitant Medication and Supportive Care Guidelines......................12
5.3
Criteria for Taking a Participant Off Protocol Therapy.........................................12
5.4
Duration of Follow Up...........................................................................................13
6.
DOSING DELAYS/DOSE MODIFICATIONS ...............................................................13
7.
ADVERSE EVENTS:  LIST AND REPORTING REQUIREMENTS ............................13
7.2
Adverse Event Characteristics ...............................................................................14
7.3
Routine Adverse Event Reporting .........................................................................14
7.4
Routine Adverse Event Reporting .........................................................................15
8.
PHARMACEUTICAL INFORMATION..........................................................................15
9.
BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES ........................................15
9.1
Biomarker Studies..................................................................................................15
9.2
Laboratory Correlative Studies..............................................................................15
9.3
Special Studies.......................................................................................................15
10.
STUDY CALENDAR .......................................................................................................16
11.
MEASUREMENT OF EFFECT........................................................................................17
11.1
Antitumor Effect – Solid Tumors ..........................................................................17
12.
DATA REPORTING / REGULATORY REQUIREMENTS...........................................18
12.1
Data Reporting.......................................................................................................18


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13.
STATISTICAL CONSIDERATIONS...............................................................................18
13.1
Study Design/Endpoints.........................................................................................18
13.2
Sample Size, Accrual Rate and Study Duration ....................................................18
13.3
Stratification Factors..............................................................................................18
13.4
Interim Monitoring Plan ........................................................................................18
13.5
Analysis of Primary Endpoints..............................................................................19
13.6
Analysis of Secondary Endpoints..........................................................................19
13.7
Reporting and Exclusions ......................................................................................19
14.
PUBLICATION PLAN .....................................................................................................19
REFERENCES ..............................................................................................................................20
APPENDIX A
Severity scoring systems............................................................................22


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1. OBJECTIVES
Objective #1. To describe the proportion of children with cutaneous reactions to targeted BRAF, 
MEK, and Pan-RAF inhibitor therapies of a cohort receiving a daily preventative skin care 
regimen (PSCR) including sun protection, gentle skin care and every other day dilute bleach 
baths at 6 and 12 weeks.
Objective #2. To describe the number of different cutaneous reactions to targeted BRAF, MEK, 
and Pan-RAF inhibitor therapies per patient in children receiving daily PSCR including sun 
protection, gentle skin care and every other day dilute bleach baths at 6 and 12 weeks.
Objective #3. To describe the severity of cutaneous reactions to targeted BRAF, MEK, and Pan- 
RAF inhibitor therapies for children receiving PSCR including sun protection, gentle skin care 
and every other day dilute bleach baths at 6 and 12 weeks. using the following severity scales: 
Common Terminology Criteria for Adverse Events (CTCAE), Overall Dry Skin Score (ODS), 
Hand-Foot Skin Reaction and Quality of Life Score (HFS-14), Pediatric Quality of Life 
Inventory (PedsQL), and Children’s Dermatology Life Quality Index (CDLQI).
1.1
Study Design
This prospective, single-arm phase 2 clinical trial will be performed at Dana-Farber 
Cancer Institute/Boston Children’s Hospital***. Additional external sites will conduct the same 
study concurrently. Data from all sites will be pooled at the end of the study and a meta-analysis 
of all aggregated data will be performed. IRB approval will be obtained prior to initiation of the 
study. This study will include patients receiving MEK inhibitor, BRAF inhibitor or pan-RAF 
inhibitor therapies for CNS and PNS tumors. At this time, we do not have the personnel or 
funding required to coordinate with multiple departments to identify all patients receiving these 
therapies.
Baseline data will be obtained from each participant via medical record review, if 
applicable. Baseline data includes, but is not limited to the following: general demographic data 
(age at tumor diagnosis, gender, race), type of primary tumor, type of therapy regimen (targeted 
therapy agents/dose/duration, chemotherapy agents/dose/duration, radiation field 
location/size/dose), past and current immunosuppressive medications, secondary malignancies 
including melanoma and nonmelanoma skin cancer, and family history of skin diseases.
All patients will undergo skin examinations at the initial study visit, mid-study visit (6 
weeks (+/- 2 weeks)), and at 12 weeks after treatment initiation. Weight-based dosing of MEK, 
BRAF, or Pan-RAF inhibitor therapies will be recorded at each visit. If any skin findings are 
present, patients and families will be asked about the timing, frequency, location and severity of 
these skin findings.
Patients will undergo a full mucocutaneous physical examination including skin, mucous 
membranes, hair, and nails during their dermatology visit. Abnormalities will be carefully 
documented, including degree of involvement (% body surface area, number of nails, % of 
scalp).


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Patients receiving targeted therapy will be evaluated specifically for the following skin 
reactions, previously reported in the literature: follicular skin rash, acneiform skin eruption, 
cheilitis, xerosis, hand foot syndrome, eruptive nevi (defined as > 5 new nevi over a 3 month 
period), keratoacanthoma, squamous cell carcinoma, photosensitivity. Undefined skin reactions 
will also be recorded.
No biopsies will be performed for research purposes. Patients who do not have a 
scheduled Dermatology visit, but have concerning findings on skin exam, will be scheduled for a 
complete dermatology evaluation, where any biopsies would be conducted as clinically indicated 
as part of routine dermatologic care.
2. BACKGROUND
2.1
Study Disease(s)
A recent study by Song et al. shows that cutaneous reactions are common in children receiving 
targeted anti-cancer therapies for CNS tumors.5 Anti-cancer therapies for children with CNS 
tumors include BRAF inhibitors (dabrafenib, vemurafenib, encorafenib) and MEK inhibitors 
(refametinib, trametinib, selunetinib, comibetinib). Cutaneous reactions occurred in 96% of the 
22 patients enrolled in this study and included xerosis, follicular eruptions, photosensitivity, 
hand-foot syndrome, eruptive nevi, nail changes, paronychia and alopecia. While most reactions 
are not life threatening, cancer therapy is frequently discontinued due to factors including 
intolerable discomfort (pain, itching) and/or concern regarding one’s appearance.6 MEK 
inhibitors have also been approved for NF-related plexiform neurofibromas, with a similar 
cutaneous reaction profile.21
Given the high incidence of cutaneous reactions to targeted tumor therapy, preventative 
measures to decrease the incidence or severity of reactions should be considered. The most 
common reactions are a result of dry skin and sun exposure; thus it is plausible that a simple 
preventative skin care regimen that addresses gentle skin care and sun protection would be 
beneficial. In addition, follicular reactions and paronychia may be ameliorated by regular use of 
dilute bleach baths, which have been shown to decrease severity of atopic dermatitis in children 
and to decrease inflammation by down-regulating the NF-kappaB pathway.7-9
Compelling in vitro and in vivo data suggests that topical hypochlorite solution markedly blocks 
NFB signaling.9 Furthermore, Leung et al demonstrated that topical hypochlorite inhibits the 
expression of NFB-dependent genes, and decreased incidence and severity of cutaneous 
reactions to anti-cancer therapy in a mouse model.9 The concentrations of hypochlorite used 
therein mirrored those determined to be safe and efficacious in dilute bleach baths used in the 
treatment of atopic dermatitis in children.10 Emerging literature in atopic dermatitis suggests that 
the mechanism by which dilute bleach baths improves skin disease is not antimicrobial,11 but 
rather, anti-inflammatory.
Bleach is an inexpensive and widely available topical agent; its use in swimming pools, medical 
clinics and commercially available cleansers speak to minimal toxicity (in dilute concentrations)


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in humans. Our aim is to determine if dilute bleach baths can attenuate the incidence and severity 
of reactions to targeted anti-cancer therapies. A study by Huang et al. surrounding dilute bleach 
baths for atopic dermatitis included children as young as 6 months of age and showed that 
patients treated with dilute bleach baths had significantly improved eczema severity10.
Cutaneous effects of targeted therapies
Over the last decade, our knowledge of the molecular composition of pediatric CNS tumors has 
increased dramatically.12 In turn, tumor specific “targeted” therapies are being developed and 
utilized at an incredible pace. Given the shared neuroectodermal origin of the brain and skin, the 
advent of these therapies has introduced new and important skin reactions, including the 
development of nevi and skin cancer during active treatment. Other associated skin reactions 
include xerosis, hand foot syndrome, follicular skin eruptions, and scalp pruritus or burning.
These reactions can be severe enough to require discontinuation or modification of therapy. 
There is also evidence in adults receiving targeted cancer therapies that presence of cutaneous 
reactions can be a good prognostic sign.
A recent study was performed by Song et al. at Boston Children’s Hospital under DFCI protocol 
# 15-5415. In this cross-sectional study, patients younger than 21 years of age receiving BRAF, 
MEK, and mTOR inhibitor monotherapy for a CNS tumor were enrolled over a one-year period. 
Full body skin examination, photographs of dermatologic findings, and initial treatment 
recommendations were included at the initial visit, and follow-up skin examinations were 
recommended every three months. Twenty-two patients were enrolled in the study. Ninety-six 
percent (21/22) of all patients had at least one skin reaction. The most common reactions across 
treatment groups included follicular/acneiform eruptions and xerosis. Two patients on MEK 
inhibitors and one patient on a BRAF inhibitor required therapy cessation due to severe 
cutaneous reactions5.
Severity Scores
In order to assess the severity of cutaneous reactions to BRAF, MEK and pan-RAF therapies, we 
will use the following scores: the Common Terminology Criteria for Adverse Events (CTCAE), 
severity of xerosis measured by the Overall Dry Skin Score (ODS), severity of hand foot 
syndrome measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14), 
Pediatric Quality of Life Inventory General Well-Being Scale (PedsQL), and the Children’s 
Dermatology Life Quality Index (CDLQI).
The Overall Dry Skin Score (ODS) is a clinical assessment of the presence and severity of skin 
dryness using a five- point scale. A score of '0' indicates no skin dryness, whereas a score of '4' 
indicates advanced skin roughness, large scales, inflammation and cracks. This score has been 
used in studies assessing skin dryness in nursing homes and pharmacies.13 The Common 
Terminology Criteria for Adverse Events (CTCAE) has a standardized grading system for 
adverse events including cutaneous reactions to anti-cancer therapies that is validated and widely 
used in oncology14. Higher grades of cutaneous reactions have significant impact on quality of 
life and can lead to interruptions in cancer treatment.
The Hand-Foot Skin Reaction and Quality of Life Score (HFS-14) is a scale that has been


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specifically developed and tested for patients with Hand-Foot Syndrome, which has been 
reported as a symptom of targeted cancer therapies. The HFS-14 questionnaire was developed 
using standardized methodology for QoL questionnaire development, which consisted of the 
following steps: gathering patient input, generating an exhaustive list of items, reducing the list 
of items, allocating items to domains, pilot testing, calculation of scores, and validation. A 
working group of experts including oncologists, a dermatologist, a public health physician, and 
health professionals having a good knowledge of HFS and day-to-day experience in the 
management of this condition was constructed for the development of this questionnaire.15 The 
PedsQL is based on a modular approach to measuring HRQOL and consists of a 15-item core 
measure of global HRQOL and eight supplemental modules assessing specific symptom or 
treatment domains. The PedsQL was empirically derived from data collected from 291 pediatric 
cancer patients and their parents at various stages of treatment.16 The Children's Dermatology 
Life Quality Index (CDLQI) is the most widely used instrument for measuring the impact of skin 
disease on quality of life (QoL) in children.17 (Olsen, 2016).
Gaps in care
While cutaneous reactions to targeted therapies are common and can be dose or treatment 
limiting, no guidelines surrounding management of these reactions currently exists. It is 
imperative for pediatric dermatologists to be involved in not only managing individual patients 
with these reactions, but also in developing protocols that assist oncologists in managing this 
population as a whole.
In a recent retrospective study of 39 adult patients who experienced cutaneous reactions to anti- 
cancer therapy, 5 experienced dose interruptions, and one patient discontinued therapy altogether 
due to severe papulosquamous rashes.18 In our experience, it is not uncommon for children to 
have treatment discontinuation due to skin rashes or reactions that are physically or emotionally 
bothersome for them. In their study, Song et al. propose an algorithm for treatment of common 
reactions, including basic skin care guidelines. However, no studies have investigated the 
efficacy of therapeutic or preventative measures.
The current skin care guidelines according to the National Cancer Institute are vague and not 
specific for different types of cancer or pediatric versus adult patients. The guidelines 
recommend using mild soaps and lotions, avoiding heating pads and ice packs, shaving less 
often, and using sunscreen and sun-protective clothing. For dry, itchy skin in reaction to cancer 
treatments, these guidelines recommend the following: “Avoid products with alcohol or perfume, 
which can dry or irritate your skin. Take short showers or baths in lukewarm, not hot, water. Put 
on lotion after drying off from a shower, while your skin is still slightly damp. Keep your home 
cool and humid. Eat a healthy diet and drink plenty of fluids to help keep your skin moist and 
healthy. Applying a cool washcloth or ice to the affected area may also help. Acupuncture also 
helps some people.”19
In addition, while there is data showing that pediatric brain tumor survivors suffer from a lower 
quality of life than healthy peers and even other childhood cancer survivors, there is no scientific 
literature that specifically addresses how cutaneous reactions to targeted anti-cancer therapy 
impact quality of life for these patients.20 Because of the high incidence of cutaneous reactions to


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MEK and BRAF inhibitor therapy, more data is needed on how cutaneous reactions to anti- 
tumor therapy impact quality of life for these patients.
3. PARTICIPANT SELECTION
3.1
Inclusion Criteria

Diagnosed with a CNS or PNS tumor between ages 6 months old -18 years old and will 
undergo treatment with at least one of the following:
1. Targeted BRAF inhibitor therapy to treat the tumor
2. Targeted MEK inhibitor therapy to treat the tumor
3. Targeted pan-RAF inhibitor therapy to treat the tumor

Patients must enroll in this trial prior to starting targeted therapy

Subjects may participate in other studies, including therapeutic trials.

Ability to comply with PSCR including sun protection, gentle skin care and every other 
day dilute bleach baths.

Ability to understand and/or the willingness of their parent or legally authorized 
representative to sign a written informed consent document.
3.2
Exclusion Criteria

Diagnosed with CNS or PNS tumor at > 18 years old

No data in medical records regarding treatment exposures

Treated with a BRAF, MEK or pan-RAF inhibitor in the last three months

Past or present allergic reaction to bleach

Past or present allergic reactions to sunscreen and/or creams, lotions, emollients to be 
utilized in this study
3.3
Inclusion of Children and Minorities
Both male and female children of all races and ethnic groups are eligible for this trial.
4. REGISTRATION AND RANDOMIZATION PROCEDURES
4.1
General Guidelines for DF/HCC*** and DF/PCC*** Institutions
Institutions will register eligible participants in the Clinical Trials Management System (CTMS) 
OnCore. Registrations must occur prior to the initiation of protocol therapy. Any participant not 
registered to the protocol before protocol therapy begins will be considered ineligible and 
registration will be denied.
An investigator will confirm eligibility criteria and a member of the study team will complete the 
protocol-specific eligibility checklist.
Following registration, participants may begin protocol therapy within one month of registration. 
Issues that would cause treatment delays should be discussed with the Overall Principal


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Investigator (PI). If a participant does not receive protocol therapy following registration within 
one month, the participant’s registration on the study must be canceled. Registration 
cancellations must be made in OnCore as soon as possible.
4.2
Registration Process for DF/HCC*** Institutions
Applicable DF/HCC*** Policy REGIST-101 must be followed.
5. TREATMENT PLAN
This study aims to enroll 8 patients who will all receive in-person and written counseling for a 
daily preventative skin care regimen (PSCR) including instructions for daily safe sun protection, 
daily gentle skin care, nail care and every other day dilute bleach baths before the initiation of 
anti-cancer therapy. Patients will be recruited by the neuro-oncology team.
The preventative skin care regimen (PSCR) is detailed below. Patients will not have to purchase 
the following materials: sunscreen, gentle cleansers, moisturizers, emollients, bleach. These 
materials will be given to patients as the first study visit.
Safe sun protection will include instructions for:

Use of SPF 30+ sunscreen with physical blockers (zinc oxide and/or titanium dioxide) 
whenever going outside

Sunscreen to be reapplied every two hours (more often as needed)

Sun-protective clothing including long sleeve, pants, wide-brimmed hat and sunglasses.
Gentle skin care will include:

Daily short, lukewarm showers and water baths

Gentle unscented cleansers (Dove, Cetaphil, Cerave, Vanicream) during bathing

Thick and unscented moisturizing creams (Cerave cream, Vanicream, Cetaphil Cream, 
Dove), and emollients (Aquaphor, Vaseline) immediately following baths or showers 
every day.
Nail care will include:

Trimming nails after bathing (fingernails once a week; toenails once a month)

Keep the fingernails trimmed with a slight curve, but the toenail straight across, to 
prevent hangnails from forming.

Do not pick loose bits off the nail to avoid tearing the nailbed or the cuticle.

Cut them off neatly with a clean, sharp pair of scissors or a nail clipper.

Avoid biting nails and trimming cuticles
Patients will also receive in-person and written counseling for every other day, 10-15 minutes 
dilute bleach baths.
Bleach baths will include:


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
Mixing ¼ cup over-the-counter household bleach with ½ full tub of lukewarm water.

Soak for 10-15 minutes

Gently pat dry

Apply gently moisturizers or emollients immediately following bathing

In the case that patients do not have access to a tub and will make bleach bath 
compresses, or if a small infant tub is used, mix 1 teaspoon of bleach with 1 every 1 
gallon of water
Patients will be asked to keep a diary of their daily skin care regimen and every-other-day dilute 
bleach baths including what products they used, how the bleach bath was made and how long 
they soaked in the bleach bath. This diary will be used to measure compliance.
If any patients develop a skin reaction to dilute bleach, they will discontinue and it will be 
documented.
If any patients develop a skin reaction to a moisturizer or sunscreen, we will recommend an 
alternative product, as we would do clinically.
Products mentioned above to be utilized in the preventative skin care regimen will be paid for by 
the Dermatology Research Fund at the Jimmy Fund Clinic***. External sites will supply their 
own sample products to participants.
5.2
Pre-Treatment Criteria
N/A
5.3
General Concomitant Medication and Supportive Care Guidelines
N/A
5.4
Criteria for Taking a Participant Off Protocol Therapy
Duration of intervention will be 12 weeks for each participant. They will receive skin 
examinations and interviews at the initiation of treatment, at 6 weeks (+/- 2 weeks) and at 12 
weeks. Reasons for taking a participant off protocol intervention include the following

Participant withdraws from targeted therapy

Intercurrent illness that prevents further administration of treatment

Unacceptable adverse event(s)

Participant demonstrates an inability or unwillingness to comply with intervention 
protocols

Participant decides to withdraw from the protocol therapy


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
General or specific changes in the participant's condition render the participant 
unacceptable for further treatment in the judgment of the treating investigator

Loss to follow-up

Withdrawal of consent for data submission

Death
Patients have the right to withdraw consent at any given time for any reason and no replacement 
is necessary as this is a single-arm trial. Participants will be removed from the protocol therapy 
when any of these criteria apply. The reason for removal from protocol therapy, and the date the 
participant was removed, must be documented in the case report form (CRF). Alternative care 
options will be discussed with the participant.
The participant’s status must be updated in OnCore in accordance with REGIST-OP-1.
In the event of unusual or life-threatening complications, treating investigators must immediately 
notify the Overall PI, Jennifer Huang at 617-355-1477***.
5.5
Duration of Follow Up
N/A
6. DOSING DELAYS/DOSE MODIFICATIONS
N/A
7. ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS
Adverse event (AE) monitoring and reporting is a routine part of every clinical trial. The 
following list of reported and/or potential AEs (Section 7.1) and the characteristics of an 
observed AE (Section 7.2) will determine whether the event requires expedited reporting in 
addition to routine reporting.
7.1.1
Adverse Event List(s) for Commercial Agent(s)
Commercial agents for preventative skin care routines include gentle soaps, lotions, 
cleansers, moisturizers, and sunscreen. Adverse events from these agents may include 
skin irritation. Patients will be referred to product information included with purchase 
of these products for possible adverse events.
Commercial agents for dilute bleach bath include OTC bleach, with 1/4 cup to be 
placed into a ½ full bathtub. Adverse events from the this commercial agent may 
include eye irritation if contact with eyes and possible skin irritation. Patients will be


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instructed to carefully avoid eye contact with bath water during dilute bleach baths 
and will be instructed to stop dilute bleach bath if skin irritation occurs following 
bleach baths.
7.2
Adverse Event Characteristics

CTCAE term (AE description) and grade: The descriptions and grading scales found 
in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version
5.0 will be utilized for AE reporting. All appropriate treatment areas should have access 
to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be 
downloaded from the CTEP web site 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.

Attribution of the AE:
-
Definite – The AE is clearly related to the study treatment.
-
Probable – The AE is likely related to the study treatment.
-
Possible – The AE may be related to the study treatment.
-
Unlikely – The AE is doubtfully related to the study treatment.
-
Unrelated – The AE is clearly NOT related to the study treatment.
7.3
Routine Adverse Event Reporting
All Adverse Events will be reported in Redcap.
7.3.1
DF/HCC*** Expedited Reporting Guidelines
Investigative sites within DF/HCC*** will report AEs directly to the DFCI Office*** for 
Human Research Studies (OHRS) per the DFCI*** IRB reporting policy.
Other investigative sites will report SAEs to their respective IRB according to the local 
IRB’s policies and procedures in reporting adverse events. A copy of the submitted 
institutional SAE form should be forwarded to the Overall PI within the timeframes 
detailed in the table below.


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DF/HCC*** Reportable AEs
Attribution
Gr. 2 & 3 
AE
Expected
Gr. 2 & 3 AE
Unexpected
Gr. 4 AE
Expected
Gr. 4 AE
Unexpected
Gr. 5 AE
Expected or 
Unexpected
Unrelated 
Unlikely
Not required
Not required
5 calendar 
days#
5 calendar 
days
24 hours*
Possible 
Probable 
Definite
Not required
5 calendar 
days
5 calendar 
days#
5 calendar 
days
24 hours*
# If listed in protocol as expected and not requiring expedited reporting, event does not need to 
be reported.
* For participants enrolled and actively participating in the study or for AEs occurring within 
30 days of the last intervention, the AE should be reported within 24 business hours of learning 
of the event.
7.4
Routine Adverse Event Reporting
All Adverse Events must be reported in routine study data submissions to the Overall PI on the 
toxicity case report forms. AEs reported through expedited processes (e.g., reported to the 
IRB, FDA, etc.) must also be reported in routine study data submissions.
8. PHARMACEUTICAL INFORMATION
A list of the adverse events and potential risks associated with the investigational or other agents 
administered in this study can be found in Section 7.1.
N/A
9. BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES
N/A
9.1
Biomarker Studies
N/A
9.2
Laboratory Correlative Studies
N/A
9.3
Special Studies
N/A


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10. STUDY CALENDAR
Section
Baseline
6 week (+/- 2
weeks) visit*
12 week visit
EDC
Timepoints
PSCR counseling
X
X
X
Baseline, 6
week, 12 
week
Informed consent
X
X
X
Baseline, 6
week, 12 
week
Demographics
X
Baseline, 6
week, 12 
week
Medical history
X
X
X
Baseline, 6
week, 12 
week
MEK, BRAF, or Pan-RAF
inhibitor dosing
X
X
X
Baseline, 6
week, 12 
week
Skin exam and interview
X
X
X
Baseline, 6
week, 12 
week
Severity Scores Completed
X
X
X
Baseline, 6
week, 12 
week
Adverse events evaluation
X
X
X
Baseline, 6
week, 12 
week
*6 week visit may be conducted virtually on request. Photographs will be requested prior to visit.


11. MEASUREMENT OF EFFECT
The measurement is the proportion (percentage) of patients with one or more cutaneous reaction 
to targeted BRAF, MEK or Pan-RAF inhibitor therapy. Secondary outcome measures include 
number of different cutaneous reactions experienced by each patient, severity of cutaneous 
reactions measured by the Common Terminology Criteria for Adverse Events (CTCAE), severity 
of xerosis measured by the Overall Dry Skin Score (ODS), severity of hand foot syndrome 
measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14), Pediatric Quality 
of Life Inventory General Well-Being Scale (PedsQL), and the Children’s Dermatology Life 
Quality Index (CDLQI). To view these assessments and scoring in detail, please see Appendix 
A.
11.1
Antitumor Effect – Solid Tumors
N/A
11.1.1 Disease Parameters
Any new or changing skin, hair or nail findings
11.1.2 Methods for Evaluation of Disease
All measurements should be taken and recorded in metric notation using a ruler, calipers, 
or a digital measurement tool. All baseline evaluations should be performed as closely as 
possible to the beginning of treatment and never more than 4 weeks before the beginning 
of the treatment.
The same method of assessment and the same technique should be used to characterize 
each identified and reported lesion at baseline and during follow-up. Imaging-based 
evaluation is preferred to evaluation by clinical examination unless the lesion(s) being 
followed cannot be imaged but are assessable by clinical exam.
Clinical lesions. In the case of skin, hair or nail lesions, documentation by color 
photography, including a ruler to estimate the size of the lesion, is recommended.
11.1.3 Response Criteria
Severity of skin reactions will be graded according to the following severity scoring systems:
Common Terminology Criteria for Adverse Events (CTCAE) (Appendix A) 
Overall Dry Skin Score (ODS) (Appendix B)
Hand-Foot Skin Reaction Quality of Life Score (HFS-14) (Appendix C) 
Children’s Dermatology Life Quality Index (CDLQI) (Appendix D) 
Pediatric Quality of Life Inventory (PedsQL)
17


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11.1.4 Response Review
Skin exams will be performed by dermatologists and trained research staff.
12. DATA REPORTING / REGULATORY REQUIREMENTS
Adverse event lists, guidelines, and instructions for AE reporting can be found in Section 7.0 
(Adverse Events: List and Reporting Requirements).
12.1
Data Reporting
Data will be reported in REDCap.  The original plan was for each of the three sites to independently 
activate the protocol, and have their own separate, but identical, REDCap electronic case report 
forms (eCRFs).  Each site has its own separate IRB approval for the trial.  However, during study 
conduct, paper CRFs from the other two sites were sent to BCH, and the other sites’ data were 
entered into the BCH REDCap eCRFs.  All data for the trial currently reside at BCH; the existence 
of data at BCH is covered by two legal Data Sharing Agreements.  All data is labeled by site.  
Keeping data transcribed as is will facilitate statistical analysis, and minimize further efforts towards 
data transfer.
13. STATISTICAL CONSIDERATIONS
Descriptive analysis of this cohort, including data from three sites, will be performed. 
13.1
Study Design/Endpoints
The primary outcome measure is cutaneous reaction to targeted BRAF, MEK, or Pan-RAF 
inhibitor therapy. Secondary outcome measures include number of different cutaneous reactions 
experienced by each patient, severity of cutaneous reactions measured by the Common 
Terminology Criteria for Adverse Events (CTCAE), severity of xerosis measured by the Overall 
Dry Skin Score (ODS), severity of hand foot syndrome measured by the Hand-Foot Skin 
Reaction and Quality of Life Score (HFS-14), Pediatric Quality of Life Inventory (PedsQL), and 
the Children’s Dermatology Life Quality Index (CDLQI).
13.2
Sample Size, Accrual Rate and Study Duration
Sample Size: 22 participants from three sites (DFCI [8], Toronto Sick Kids [7], Lurie Children’s 
Hospital [7])
Accrual Rate: 6 participants / 1 year
Study duration: ~3 years (3 years of accrual + 12 weeks of treatment on the last patient 
enrolled)
This sample size is limited due to the rare nature of these cancers, but a total of 22 will be 
sufficient for descriptive analyses. The study team believes that accrual of more than 8 patients 
in a one year period at DFCI/BCH*** is not feasible.
13.3
Stratification Factors
N/A


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13.4
Interim Monitoring Plan


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N/A
13.5
Analysis of Primary Endpoints
In the overall cohort, the proportion of patients with one or more cutaneous reactions will be 
calculated, and a 95% exact confidence interval will be placed on this proportion.
13.6
Analysis of Secondary Endpoints
In the overall cohort, the minimum, maximum, and quartiles of the number of cutaneous 
reactions per patient will be calculated.
In the overall cohort: To describe the severity of cutaneous reactions, the proportion of patients 
at each CTCAE grade of toxicity, and for each grade of the Overall Dry Skin Score (ODS), will 
be calculated. For each of the following severity scales, the minimum, maximum, and quartiles 
of the scores will be calculated: Hand-Foot Skin Reaction and Quality of Life Score (HFS-14), 
Pediatric Quality of Life Inventory (PedsQL), and Children’s Dermatology Life Quality Index 
(CDLQI).
13.7
Reporting and Exclusions
N/A
13.7.1 Evaluation of Toxicity
N/A
13.7.2 Evaluation of the Primary Efficacy Endpoint
N/A
14. PUBLICATION PLAN
The results should be made public within 24 months of reaching the end of the study. The end of 
the study is the time point at which the last data items are to be reported, or after the outcome 
data are sufficiently mature for analysis, as defined in the section on Sample Size, Accrual Rate 
and Study Duration.


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REFERENCES
1.
Green AL, Kieran MW. Pediatric brainstem gliomas: new understanding leads to 
potential new treatments for two very different tumors. Curr Oncol Rep. 
2015;17(3):436.DOI: 10.1007/s11912-014-0436-7
2.
Penman CL, Faulkner C, Lowis SP, Kurian KM. Current Understanding of BRAF 
Alterations in Diagnosis, Prognosis, and Therapeutic Targeting in Pediatric Low-Grade 
Gliomas. Front Oncol. 2015;5:54.DOI: 10.3389/fonc.2015.00054
3.
Boussemart L, Routier E, Mateus C, Opletalova K, Sebille G, Kamsu-Kom N, et al. 
Prospective study of cutaneous side-effects associated with the BRAF inhibitor 
vemurafenib: a study of 42 patients. Ann Oncol. 2013;24(6):1691-1697.DOI: 
10.1093/annonc/mdt015
4.
Sinha R, Larkin J, Gore M, Fearfield L. Cutaneous toxicities associated with vemurafenib 
therapy in 107 patients with BRAF V600E mutation-positive metastatic melanoma, 
including recognition and management of rare presentations. Br J Dermatol. 
2015;173(4):1024-1031.DOI: 10.1111/bjd.13958
5.
Song H, Zhong CS, Kieran MW, Chi SN, Wright KD, Huang JT. Cutaneous reactions to 
targeted therapies in children with CNS tumors: A cross-sectional study. Pediatr Blood 
Cancer. 2019:e27682.DOI: 10.1002/pbc.27682
6.
Boull C, Hook K, Moertel C, Maguiness S. Cutaneous Reactions in Children Treated 
with the Mitogen-Activated Protein Kinase Extracellular Signal-Regulated Kinase 
Inhibitor Trametinib for Neural Tumors. Pediatr Dermatol. 2017;34(1):90-94.DOI: 
10.1111/pde.13038
7.
Chopra R, Vakharia PP, Sacotte R, Silverberg JI. Efficacy of bleach baths in reducing 
severity of atopic dermatitis: A systematic review and meta-analysis. Ann Allergy Asthma 
Immunol. 2017;119(5):435-440.DOI: 10.1016/j.anai.2017.08.289
8.
Huang JT, Rademaker A, Paller AS. Dilute bleach baths for Staphylococcus aureus 
colonization in atopic dermatitis to decrease disease severity. Arch Dermatol. 
2011;147(2):246-247.DOI: 10.1001/archdermatol.2010.434
9.
Leung TH, Zhang LF, Wang J, Ning S, Knox SJ, Kim SK. Topical hypochlorite 
ameliorates NF-kappaB-mediated skin diseases in mice. J Clin Invest. 
2013;123(12):5361-5370.DOI: 10.1172/JCI70895
10.
Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of 
Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. 
Pediatrics. 2009;123(5):e808-814.
11.
Sawada Y, Tong Y, Barangi M, et al. Dilute bleach baths used for treatment of atopic 
dermatitis are not antimicrobial in vitro. J Allergy Clin Immunol. 2019;143(5):1946-1948.
12.
Nikiforova MN, Wald AI, Melan MA, Roy S, Zhong S, Hamilton RL, et al. Targeted 
next-generation sequencing panel (GlioSeq) provides comprehensive genetic profiling of 
central nervous system tumors. Neuro Oncol. 2016;18(3):379-387.DOI: 
10.1093/neuonc/nov289
13.
Kang BC, Kim YE, Kim YJ, Chang MJ, Choi HD, Li K, et al. Optimizing EEMCO 
guidance for the assessment of dry skin (xerosis) for pharmacies. Skin Res Technol. 
2014;20(1):87-91.DOI: 10.1111/srt.12089


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14.
Services. UDoHaH. Common Terminology Criteria for Adverse Events 
(CTCAE) v5.0.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Q 
uick_Reference_5x7.pdf. Published 2017. Accessed July 25, 2019.
15.
Sibaud V, Dalenc F, Chevreau C, Roche H, Delord JP, Mourey L, et al. HFS-14, a 
specific quality of life scale developed for patients suffering from hand-foot syndrome. 
Oncologist. 2011;16(10):1469-1478.DOI: 10.1634/theoncologist.2011-0033
16.
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality 
of life inventory. Med Care. 1999;37(2):126-139.DOI: 10.1097/00005650-199902000- 
00003
17.
Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Quality of life impact of 
childhood skin conditions measured using the Children's Dermatology Life Quality Index 
(CDLQI): a meta-analysis. Br J Dermatol. 2016;174(4):853-861.DOI: 10.1111/bjd.14361
18.
Yalici-Armagan B, Tugrul Ayanoglu B, Demirdag HG. Targeted Tumour Therapy 
Induced Papulopustular Rash and Other Dermatologic Side Effects: A Retrospective 
Study. Cutan Ocul Toxicol. 2019:1-27.DOI: 10.1080/15569527.2019.1594874
19.
National Cancer Institute Skin Care Guidelines
https://www.cancer.gov/about-cancer/treatment/side-effects/skin-nail-changes.
20.
Macartney G, Harrison MB, VanDenKerkhof E, Stacey D, McCarthy P. Quality of life 
and symptoms in pediatric brain tumor survivors: a systematic review. J Pediatr Oncol 
Nurs. 2014;31(2):65-77.DOI: 10.1177/1043454213520191
21.
Dombi E, Baldwin A, Marcus LJ, Fisher MJ, Weiss B, Kim A, Whitcomb P, Martin S, 
Aschbacher-Smith LE, Rizvi TA, et al. Activity of selumetinib in neurofibromatosis type 
1-related plexiform neurofibromas. N Engl J Med. 2016;375(26):2550–60.


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APPENDIX A
SEVERITY SCORING SYSTEMS
1. Common Terminology Criteria For Adverse Events Version 5.0 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm


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2. Overall Dry Skin Score (ODS), EEMCO Guidelines
Kang BC, Kim YE, Kim YJ, Chang MJ, Choi HD, Li K, et al. Optimizing EEMCO guidance for 
the assessment of dry skin (xerosis) for pharmacies. Skin Res Technol. 2014;20(1):87-91.DOI: 
10.1111/srt.12089
Score
Description
0
Absent
1
Faint scaling, faint roughness, and dull appearance
2
Small scales in combination with a few larger scales, slight 
roughness, whitish appearance
3
Small and larger scales uniformly distributed, definite roughness, 
possibly slight redness and possibly a few superficial cracks
4
Dominated by large scales, advanced roughness, redness present, 
eczematous redness and cracks


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3. Hand-Foot Skin Reaction Quality of Life Score (HFS-14)
Sibaud V, Dalenc F, Chevreau C, Roche H, Delord JP, Mourey L, et al. HFS-14, a specific 
quality of life scale developed for patients suffering from hand-foot syndrome. Oncologist. 
2011;16(10):1469-1478.DOI: 10.1634/theoncologist.2011-0033
Scoring:
Each item is scored on a three-point Likert scale: 0, “no, never”; 1, “yes, from time to time”; 2, 
“yes, always.” Two separate questions include one to measure limb involvement (type of limb 
affected by HFS, one or both) and one to measure pain. The limb involvement item is scored 
either 1 if only the hands or feet were affected or 3 if both the hands and feet were affected. The 
pain item is scored on a three-point scale: 1, not painful; 2, moderately painful; 3, very painful. 
The total HFS-14 score is calculated by summing the scores of all items, with the higher the 
score, the greater the QoL impairment.


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4. Children’s Dermatology Life Quality Index (CDLQI) 
(Illustrations not included)
Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial 
validation and practical use. Br J Dermatol. 1995;132(6):942-949
https://astar-register.org/wp-content/uploads/sites/284/2018/10/CDLQI-Cartoon 
English-V1-16Oct18.pdf
How to score it
The scoring of each question is:

Very much = 3

Quite a lot = 2

Only a little = 1

Not at all = 0

Question unanswered = 0

Question 7: 'Prevented school' (text-only questionnaire) = 3


Meaning of scores

0-1 = no effect on child’s life

2-6 = small effect

7-12 = moderate effect

13-18 = very large effect

19-30 = extremely large effect
Please Check EVERY question. 
Over the last week:
1. How itch, ‘scratchy,’ sore or painful has your skin been? 
Very much
Quite a Lot 
A Little 
Not at all
2. How upset or embarrassed, self-conscious, or sad have you been because of your skin? 
Very much
Quite a Lot 
A Little 
Not at all


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3. How much has your skin affected your friendships?
Very much 
Quite a Lot 
A Little 
Not at all
4. How much have you changed or worn different or special clothes/shoes because of your 
skin?
Very much 
Quite a Lot 
A Little 
Not at all
5. How much has your skin trouble affected going out, playing or doing hobbies?
Very much 
Quite a Lot 
A Little 
Not at all
6. How much have you avoided swimming or other sports because of your skin trouble? 
Very much
Quite a Lot 
A Little 
Not at all
7a. If school time: How much did your skin trouble affect your school work?
Very much 
Quite a Lot 
A Little 
Not at all
7b. If holiday time: How much has your skin problem interfered with your holiday plans?
Very much 
Quite a Lot 
A Little 
Not at all
8. How much trouble have you had with your skin with other people calling your names, 
teasing, bullying, asking questions, or avoiding you?
Very much 
Quite a Lot 
A Little 
Not at all
9. How much has your sleep been affected by your skin problem? 
Very much
Quite a Lot


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A Little 
Not at all
10. How much of a problem has the treatment for your skin been? 
Very much
Quite a Lot 
A Little 
Not at all
5. Pediatric Quality of Life Score, General Well-Being Scale 
https://www.pedsql.org/
For scaling and scoring: 
https://www.pedsql.org/PedsQL-Scoring.pdf

ICF_001.pdf: 
Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 1 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
Protocol Title: PREVENTATIVE SKIN CARE FOR CHILDREN UNDERGOING TARGETED 
THERAPY FOR CNS AND PNS TUMORS
DF/HCC Principal Research Doctor / Institution:   
Jennifer Huang, MD; Dana-Farber Cancer Institute & Boston Children’s Hospital
Main Consent
Version 16JUN2021
If you are a parent or guardian of a child under 18 years old, the word “you” 
refers to your child. You, the parent, will be asked to read and sign this document 
to give permission for your child to participate.  
INTRODUCTION AND KEY INFORMATION
All research is voluntary. It is your choice whether you take part in this research 
or not. If you decide to participate, please sign and date at the end of this form. 
We will give you a copy and you can refer to this consent form at any time.
The following is a short summary of this research study to help you decide 
whether you would like to be a part of this study. More detailed information is 
provided later in this form. 
 
For purposes of this research, you will be referred to as a “participant.”  
1. Why am I being invited to take part in a research study?
You are invited to take part in in this research study, because you have been 
diagnosed with a nervous system tumor and you will be receiving anti-cancer 
therapy with a MEK, Pan-RAF, or BRAF inhibitor.
2. Why is this research being done? 
This research study will help us learn more about preventing skin changes that 
may occur in children who are getting treatment for nervous system tumors. We 
are interested in knowing whether gentle skin care, nail care, sun protection and 
dilute bleach baths might decrease the chances or the severity of skin changes 


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 2 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
that occur during treatment for nervous system tumors. This information may 
help us treat nervous system tumor patients in the future.
3. Who is supporting this research?
Boston Children’s Hospital is supporting this research study.  
Preventative skin care regimen materials including bleach, sunscreen, soap, 
lotion and emollients will be provided by the Dermatology Research Fund at the 
Jimmy Fund Clinic. 
4. What does this research study involve and how long will it last?
Before the research starts: 
The research study procedures include screening for eligibility and study 
treatment including evaluations and follow up visits.
You will receive a study treatment regimen that involves a preventative skin care 
routine along with regular dilute bleach baths. You will be followed for twelve 
weeks. 
It is expected that about 8 people will take part in this research study. 
Information about you and your health is personal and private. Generally it 
cannot be obtained without your written permission. By signing this form, you are 
providing that permission and your information may be obtained and used in 
accordance with this informed consent and as required or allowed by law. This 
means that researchers may obtain information regarding your past medical 
history, as well as specimens and samples from previous health care providers 
such as hospitals and labs.
5. What are the risks to participating in this study?
There are risks to taking part in any research study. The following are the risks 
associated with this particular study.

You will have complete skin examinations at the initiation of your 
treatment, at six weeks after the start of your treatment, and at twelve 


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 3 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
weeks after the start of your treatment, which may give you physical or 
emotional discomfort.

You may be instructed to use sunscreen and/or lotions that you have not 
used before that may cause skin reactions.

You may be instructed to undergo regular, dilute bleach baths at home 
that may cause skin reactions.

You may feel uncomfortable about answering certain questions about your 
health.

We may find something on your skin that requires follow up or skin biopsy.

You may experience skin reactions to your cancer treatment despite skin 
care routines used during the study period.
6. Will being in this study benefit me in any way?
Taking part in this research study may or may not benefit you. We hope the 
information learned from this research study will provide more information about 
preventing skin changes that occur in children with brain tumors. 
7.  What are my options?
Taking part in this research study is voluntary. Instead of being in this research 
study, you have the following options:

Decide not to participate in this research study
You have the right to choose not to sign this form. If you decide not to sign this 
form, you cannot participate in this research study. 
You can stop being in the research study at any time. Leaving the research study 
will not affect your medical care. You can still get your medical care from your 
hospital or Investigator.  
If you choose to not participate, or if you are not eligible to participate, or if you 
withdraw from this research study, this will not affect your present or future care 
and will not cause any penalty or loss of benefits to which you are otherwise 
entitled.  


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 4 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
A. WHY IS THIS RESEARCH STUDY BEING DONE?
Some chemotherapy agents such as MEK, BRAF and pan-RAF inhibitors can 
cause skin problems as a side effect. The can include problems such as sunburn 
and rashes. This research study will help us learn more about preventing these 
skin changes that may occur in children who are getting treatment for nervous 
system tumors. We are interested in knowing whether gentle skin care, nail care, 
sun protection and dilute bleach baths might decrease the chances or the 
severity of skin changes that occur during treatment for nervous system tumors. 
This information may help us treat nervous system tumor patients in the future.
B. WHAT IS INVOLVED IN THE RESEARCH STUDY?
You will be asked to perform a preventative skin care routine that includes daily 
sun protection, daily gentle skin care, nail care and every-other-day dilute bleach 
baths for the duration of the study
Before the research starts (screening):  
Before participating in this research study, we will ask you some questions to find 
out if you can be in the research study. Your clinic and hospital records will also 
be reviewed.
If these tests show that you are eligible to participate in the research study, you 
will be eligible to participate in the research study. If you do not meet the 
eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate 
in the research study:  
Skin exams will be performed at three different times. The first exam will take 
place at the beginning of your treatment, the second exam will take place at six 
weeks after start of your treatment and the third exam will take place at twelve 
weeks after the start of your treatment. 
At your visits:

You will have a complete examination of your skin, hair, and nails.

Photographs will be taken of your skin, hair, and nails.


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 5 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 

If you are under 12 years of age, you and your legal guardian will 
complete written surveys about any skin changes you have experienced 
since starting treatment. If you are 12 years of age or older, you can 
complete these surveys by yourself.

The visit will take 30 minutes to 1 hour of your time.
You will receive counseling about gentle skin care, nail care and sun protection. 
You will be asked to:
1. Take short warm, not hot, showers or baths.
2. Use one of several recommended moisturizers immediately after bathing.
3. Wear mineral based sunscreen of SPF 30 or higher on a daily basis on all 
sun exposed areas.
4. Wear sun protective clothing when outdoors.
5. Limit sun exposure during peak hours of 10am-4pm.
6. Take warm 10-15 minute dilute bleach baths every other day
7. Trim your fingernails once a week and your toenails once a month after 
bathing
During the study, information will also be obtained from your clinic and hospital 
records including blood tests, physical exam findings, past and current 
medications, past and current medical history, biopsy results, and 
hospitalizations.
Research Study Plan:
Baseline
6 weeks
12 weeks
History
X
X
X
Physical exam
X
X
X
Written surveys
X
X
X
Dry skin care, nail 
care, sun 
protection, and 
dilute bleach bath 
counseling
X
If you are enrolled in this study, you will be in this research study during the 
course of your treatment. At the initial visit when you start treatment, at six weeks 


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
OHRS 6.17.2019
Page 6 of 19
DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
after the start of your treatment, and at twelve weeks after the start of your 
treatment, you will receive a full skin examination and be asked to complete 
surveys about any skin changes you have experienced during this time.
Planned Follow-up: 
We would like to keep track of your medical condition. Keeping in touch with you 
and checking your condition helps us look at the long-term effects of the research 
study.  
In addition, you can stop participating in the research study at any time, however, 
the FDA requires that any information collected up to the point of your withdrawal 
cannot be removed from the study.
C. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY?
There are risks to taking part in any research study. The following are the risks 
associated with this particular study.

You will have complete skin examinations at the initiation of your 
treatment, at six weeks after the start of your treatment, and at twelve 
weeks after the start of your treatment, which may give you physical or 
emotional discomfort.

You may be instructed to use sunscreen and/or lotions that you have not 
used before that may cause skin reactions.

You may be instructed to undergo regular, dilute bleach baths at home 
that may cause skin reactions.

You may feel uncomfortable about answering certain questions about your 
health.

We may find something on your skin that requires follow up or skin biopsy.

You may experience skin reactions to your cancer treatment despite skin 
care routines used during the study period.

In a research study, all of the risks or side effects may not be known 
before you start the study.
At your visit, you will be given an opportunity to discuss any concerns you have 
about the study. We will do our best to minimize your discomfort or 
inconvenience. If at any time, this study becomes too burdensome, you have the 
right to discontinue participation in this study.  


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DFCI Protocol Number: 19-579 
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Date Posted for Use: 12/14/2021 
During the research study, you will be provided with any new information that 
may affect your health or willingness to participate. You may be asked to sign a 
new consent form that shows that you have been informed of new information 
relating to this research study.
If we find something concerning on your skin, we will recommend appropriate 
care, which may include a follow up appointment or skin biopsy. If you are being 
evaluated during your oncology visit, rather than a dermatology visit, you will be 
scheduled for a formal dermatology visit in order to provide you with appropriate 
dermatologic care.
If you experience any adverse reactions to the skin care routines utilized in this 
study, including sunscreens, lotions, creams or dilute bleach baths, you will be 
instructed to discontinue them. 
D. WHAT WILL HAPPEN IF I AM REMOVED FROM THE STUDY OR DECIDE TO END MY 
PARTICIPATION IN THE RESEARCH?
You may be taken off the research study for any reason including:

It is considered to be in your best interest

The study treatment or procedures are found to be unsafe or ineffective

There is any problem with following study treatments and procedures

Your condition worsens

A decision is made to end the study

Or for other unforeseen reasons that make it necessary to stop your 
participation in the research study
You can also choose to stop participating in the research study at any time. Tell 
the research doctor if you are thinking about stopping or decide to stop.  He or 
she will tell you how to stop.  Leaving the research study will not affect your 
medical care outside of the research study.  
If you decide to withdraw from a study that involves de-identified data it will not 
be possible to remove the data that have already been submitted to a database.   


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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
E. WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY?
You will not be paid for participating in this study. 
F. WHAT ARE YOUR COSTS?
Taking part in this research study will not lead to added costs to you or your 
insurance company. 
Preventative skin care regimen materials including bleach, sunscreen, soap, 
lotion and emollients will be provided by the Dermatology Research Fund at the 
Jimmy Fund Clinic. 
You will not be charged for the following that are part of this research study:

Dermatology visit (if you weren’t scheduled to see Dermatology as part of 
your clinic visit) 
You or your insurance company will be charged for other portions of your care 
during this research study that are considered standard of care. You may be 
responsible for co-payments and deductibles that are standard for your insurance 
coverage. 
If you have questions about your insurance coverage, or the items you might be 
required to pay for, please call financial services for information. The contact 
information for financial services: 

Boston Children’s Hospital: (617) 355-3397

Dana-Farber Cancer Institute: (617) 632-3455
The National Cancer Institute provides an online resource to help people 
participating in cancer clinical trials understand which services their insurance 
company is required by law to pay. This can be found at the website below.
http://www.cancer.gov or 1-800-4-CANCER (1-800-422-6237)


Research Consent Form
Dana-Farber/ Harvard Cancer Center
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OHRS 6.17.2019
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
G. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN 
THIS RESEARCH STUDY?
If you think you have been injured as a result of taking part in this research 
study, tell the person in charge of this research study as soon as 
possible. The research doctor’s name and phone number are listed in this 
consent form.
The treating hospital will offer you the care needed to treat injuries directly 
resulting from taking part in this research. These treatments may be billed 
to you or your insurance company. You will be responsible for deductibles, 
co-payments and co-insurance. There are no plans to pay you or give you 
other compensation for the injury. 
You do not give up your legal rights by signing this form. 
 
We will need to collect certain personal information about you for 
insurance or payment reporting purposes, such as your name, date of 
birth, gender, social security number or Medicare identification number 
and information related to this research study. We may be required to 
report this information to the Centers for Medicare & Medicaid Services. 
We will not use this information for any other purpose.
If you go to the Emergency Room or to another hospital or doctor it 
is important that you tell them that you are in this research. If 
possible, you should give them a copy of this consent form.
H. WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY?
If you have questions about the study, please contact the research Investigator 
or study staff as listed below:
Dana-Farber Cancer Institute & Boston Children’s Hospital

Jennifer Huang, MD 617-355-6117
24-hour contact: DFCI & BCH: Jennifer Huang, MD at 617-355-6117 or page at 
617-355-6000, beeper 2289. 


Research Consent Form
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates 
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
For questions about your rights as a research participant, please contact a 
representative of the Office for Human Research Studies at DFCI (617) 632-
3029. This can include questions about your participation in the study, concerns 
about the study, a research related injury, or if you feel/felt under pressure to 
enroll in this research study or to continue to participate in this research study. 
For questions about your rights as a research participant, please contact a 
representative of the Office for Human Research Studies at Dana-Farber Cancer 
Institute (617) 632-3029. This can include questions about your participation in 
the study, concerns about the study, a research related injury, or if you feel/felt 
under pressure to enroll in this research study or to continue to participate in this 
research study. 
I.
RETURN OF RESEARCH RESULTS
Tests done in this research study are only for research and have no clear 
meaning for your health care. For this reason, your study doctor will not share the 
results with you.
J. CLINICALTRIALS.GOV 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This web site will not include information that can 
identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time.
K. FUTURE USE OF DATA AND SPECIMENS
Your personal information and/or biospecimens collected during this study may 
be stored and used for future research. Any personal identifiers will be removed, 
before they are shared, so that the information or samples cannot be linked back 
to you. 
L. CONFIDENTIALITY
We will take measures to protect the privacy and security of all your personal 
information, but we cannot guarantee complete confidentiality of study data.  


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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
Medical information created by this research study may become part of your 
hospital medical record and may be forwarded to your primary doctor. 
Information that does not become part of your medical record will be stored in 
your study file. It may also become part of a research database.  
The study team plans to publish the results of this research study and when we 
do, we may be asked to make the data we collect available to other researchers. 
We will not include information that identifies you in any publications or to the 
researchers who request the data to do additional research.
There is a risk that de-identified research data that is shared with outside 
collaborators may be re-identified. When de-identified data are shared with 
outside collaborators agreements limit what the outside collaborators can do with 
the information to help prevent re-identification.  
M.  FINANCIAL DISCLOSURES
It is possible that certain researchers on this study may have earned money 
from, or own some publicly-traded stock in, the company that makes or is 
developing the study. The amount of money that a researcher may earn and still 
take part in research is limited by the Harvard Medical School Faculty of 
Medicine Policy on Conflicts of Interest and Commitment. If you have further 
questions, please speak with a member of the study team or contact the Dana-
Farber Cancer Institute Office of Research Integrity at 617-432-4557 or 
researchintegrity@dfci.harvard.edu.
N. PRIVACY OF PROTECTED HEALTH INFORMATION (HIPAA AUTHORIZATION)
The Health Insurance Portability and Accountability Act (HIPAA) is a federal law 
that requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated 
research doctors, health care providers, and physician network to protect the 
privacy of information that identifies you and relates to your past, present, and 
future physical and mental health conditions (“protected health information”). If 
you enroll in this research study, your “protected health information” will be used 
and shared with others as explained below.


Research Consent Form
Dana-Farber/ Harvard Cancer Center
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OHRS 6.17.2019
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
1. What protected health information about me will be used or shared with 
others during this research?

Existing medical records, including mental health records.

New health information created from study-related tests, procedures, 
visits, and/or questionnaires
2. Why will protected information about me be used or shared with others?
The main reasons include the following:

To conduct and oversee the research described earlier in this form;

To ensure the research meets legal, institutional, and accreditation 
requirements; 

To conduct public health activities (including reporting of adverse events 
or situations where you or others may be at risk of harm); and

To provide the study sponsor with information arising from an adverse 
event or other event that relates to the safety or toxicity of the drug(s) 
used in the study and for the purpose of this or other research relating the 
study drug(s) and their use in cancer; 

To better understand the diseases being studied and to improve the 
design of future studies; and,

Other reasons may include for treatment, payment, or health care 
operations.  For example, some medical information produced by this 
research study may become part of your hospital medical record because 
the information may be necessary for your medical care. (You will also be 
given a notice for use and sharing of protected health information.)
3. Who will use or share protected health information about me?

DF/HCC and its affiliated research doctors and entities participating in the 
research will use and share your protected health information. In addition, 
other DF/HCC offices that deal with research oversight, billing or quality 
assurance will be able to use and share your protected health information.


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DFCI Protocol Number: 19-579 
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Date Posted for Use: 12/14/2021 
4. With whom outside of DF/HCC may my protected health information be 
shared?
While all reasonable efforts will be made to protect the confidentiality of your 
protected health information, it may also be shared with the following entities:

Outside individuals or entities that have a need to access this information 
to perform functions relating to the conduct of this research such as 
analysis by outside laboratories on behalf of DF/HCC and its affiliates (for 
example, data storage companies, insurers, or legal advisors).

The sponsor(s) of the study, its subcontractors, representatives, business 
partners, and its agent(s): Boston Children’s Hospital 

Other research doctors and medical centers participating in this research, 
if applicable

Federal and state agencies (for example, the Department of Health and 
Human Services, the Food and Drug Administration, the National 
Institutes of Health, and/or the Office for Human Research Protections), or 
other domestic or foreign government bodies if required by law and/or 
necessary for oversight purposes. A qualified representative of the FDA 
and the National Cancer Institute may review your medical records.

Hospital accrediting agencies

A data safety monitoring board organized to oversee this research, if 
applicable
Some who may receive your protected health information may not have to 
satisfy the privacy rules and requirements. They, in fact, may share your 
information with others without your permission. 
5. For how long will protected health information about me be used or 
shared with others?

There is no scheduled date at which your protected health information that 
is being used or shared for this research will be destroyed, because 
research is an ongoing process.  


Research Consent Form
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
6. Statement of privacy rights:

You have the right to withdraw your permission for the research doctors 
and participating DF/HCC entities to use or share your protected health 
information.  We will not be able to withdraw all the information that 
already has been used or shared with others to carry out related activities 
such as oversight, or that is needed to ensure quality of the study. To 
withdraw your permission, you must do so in writing by contacting the 
researcher listed above in the section: “Whom do I contact if I have 
questions about the research study?”

You have the right to request access to your protected health information 
that is used or shared during this research and that is related to your 
treatment or payment for your treatment, but you may access this 
information only after the study is completed.  To request this information, 
please contact the researcher listed above in the section: “Whom do I 
contact if I have questions about the research study?”


Research Consent Form
Dana-Farber/ Harvard Cancer Center
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
O. DOCUMENTATION OF ASSENT
Signature of participant between age of 10 and 18: The person doing this 
research study has explained what will happen to me if I take part in this 
research study. My signature below means that I want to be in this research 
study. I can decide not to take part in this research study if I do not want to and 
nothing will happen to me if I decide I do not want to participate.  
____________________________________
__________________
Signature of Participant
Date
To be completed by person obtaining assent:
The assent discussion was initiated on  
 (date). 
The information was presented in age-appropriate terms.  The minor:
Agreed to take part in the study
Did not agree to take part in the study
An assent discussion was not initiated with the minor for the following reason(s):
Minor is incapacitated
Minor is under 10 years of age
Other
Signature of Individual obtaining assent: 
Printed name of above: 
Date: 


Research Consent Form
Dana-Farber/ Harvard Cancer Center
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
P. DOCUMENTATION OF CONSENT
My signature below indicates:

I have had enough time to read the consent and think about 
participating in this study;

I have had all of my questions answered to my satisfaction;

I am willing to participate in this study;

I have been told that my participation is voluntary and I can withdraw at 
any time
Signature of Participant
Date
or Legally Authorized Representative  
Relationship of Legally Authorized Representative to Participant  


Research Consent Form
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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
To be completed by person obtaining consent:
Adult Participant
The consent discussion was initiated on  
 (date).
Signature of individual obtaining consent: 
Printed name of above: 
Date: 
A copy of this signed consent form will be given to the participant or legally authorized 
representative.
 1)  The participant is an adult and provided consent to participate.
1a)  Participant (or legally authorized representative) is a non-English speaker and
signed the translated Short Form in lieu of English consent document:
  As someone who understands both English and the language used by the participant, I     
interpreted and/or witnessed, in the participant’s language, the researcher’s presentation of 
the English consent form.  The participant was given the opportunity to ask questions. 
Signature of Interpreter/Witness: 
Printed Name of Interpreter/Witness: 
Date: 
1b)  Participant is physically unable to sign the consent form because: 
 The participant is illiterate.
 The participant has a physical disability.
 Other (please describe): _________________________________________
The consent form was presented to the participant who was given the opportunity 
to ask questions and who communicated agreement to participate in the research. 
Signature of Witness: 
Printed Name of Witness: 
Date: 
2)  The participant is an adult who lacks capacity to provide consent and his/her legally 
authorized representative:


Research Consent Form
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DFCI Protocol Number: 19-579 
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Date Posted for Use: 12/14/2021 
2a) gave permission for the adult participant to participate 
2b) did not give permission for the adult participant to participate 
To be completed by person obtaining consent:
Minor Participant
The consent discussion was initiated on  
 (date).
Signature of individual obtaining consent: 
Printed name of above: 
Date: 
A copy of this signed consent form will be given to the participant or legally authorized 
representative, or, where the participant is a minor, the participant’s parent or legal guardian.
1) The parent or legally authorized representative gave permission for the minor to 
participate.
1a) Parent or legally authorized representative is a non-English speaker and signed
the translated Short Form in lieu of English consent document
As someone who understands both English and the language spoken by the participant, I 
interpreted and/or witnessed, in the participant’s language, the researcher’s presentation 
of the English consent form.  The participant was given the opportunity to ask questions. 
Signature of Interpreter/Witness: 
Printed name of Interpreter/Witness: 
Date: 
1b) Parent or legally authorized representative is physically unable to sign the consent 
form because: 
 The participant is illiterate.
 The participant has a physical disability.
 Other (please describe): _________________________________________
The consent form was presented to the parent or legally authorized representative
who was given the opportunity to ask questions and who communicated agreement for the 
minor to participate in the research. 
Signature of Witness: 
Printed Name of Witness: 


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DFCI Protocol Number: 19-579 
Approved Date (DFCI IRB Approval): 12/10/2021 
Date Posted for Use: 12/14/2021 
Date: 
1c) The parent or legally authorized representative did not give permission for the minor to 
participate