Clinical trial NCT04479514: Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Official title: Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediatric Cancer
CNS Tumor, Childhood
Skin Inflammation
Keywords: Pediatric Cancer
CNS Tumor, Childhood
Skin Inflammation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a brain 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 brain tumor
  2. Targeted MEK inhibitor therapy to treat the brain tumor
  3. Targeted pan-RAF inhibitor therapy to treat the brain tumor
* 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.

Exclusion Criteria:

* Diagnosed with brain 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

Primary outcomes:
measure: Rate of Cutaneous Reaction
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Cutaneous Reaction Severity
timeFrame: 12 weeks
measure: Xerosis Severity
timeFrame: 12 weeks
measure: Hand Foot Syndrome Severity
timeFrame: 12 weeks
measure: Pediatric Quality of Life
timeFrame: 12 weeks
measure: Children's Dermatology Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jennifer Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: