Conditions: Radiation Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.

Detailed description:

Arms:
arm 1: The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT. arm 2: Patients in the control arm will be treated according to standard of care without any radiation dermatitis prophylaxis.

Interventions: intervention 1: Chlorhexidine gluconate solution intervention 2: Mupirocin Ointment
Intervention descriptions: intervention 1: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body. intervention 2: Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.

Protocol document:
Prot_SAP_000.pdf: 
Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
 1 
 
 
 
 
 
 
 
Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized 
Controlled Trial and Quality of Life Assessment 
 
 
NCT #03883828 
 
Study Protocol  
 
 
Document Date 5/13/19 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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Table of Contents 
1. Description of the study ............................................................................................ 3 
2. Background ............................................................................................................. 3-4 
3. Objectives ................................................................................................................... 4 
4. Study Design .............................................................................................................. 4 
4.1 Subject inclusion criteria ..................................................................................... 4 
4.2 Patient exclusion criteria ..................................................................................... 4 
4.3 Recruitment ........................................................................................................... 4 
4.4 Study procedures ................................................................................................. 5 
4.5 Study calendar and timeline ............................................................................. 6-7 
4.6 Consent ................................................................................................................. 7 
5. Statistical analysis and sample size calculation: ................................................ 7-8 
6. Data monitoring and safety ....................................................................................... 8 
6.1 Data storage .......................................................................................................... 8 
6.2 Confidentiality ....................................................................................................... 8 
6.3 Source documents ............................................................................................... 9 
6.4 Adverse reporting and monitoring ................................................................. 9-10 
7. Appendix ................................................................................................................... 10 
8. References ................................................................................................................ 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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1. Description of the study:  
 
The purpose of this study is to determine whether bacterial decolonization of the 
nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the 
head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve 
quality of life. This study is being conducted because prior studies from this research 
group have found bacterial colonization in the nose prior to initiation of RT to be 
associated with an increased risk of high grade RD. Patients in the treatment arm will 
receive pretreatment with mupirocin ointment to the nares and chlorhexidine gluconate 
wash to the body, while patients in the control arm will receive standard of care treatment. 
Bacterial cultures will be taken from the nares, radiated skin, and site contralateral to 
radiation at baseline and at completion of RT from all participants. If severe infection 
requiring systemic antibiotics occurs, we may obtain additional cultures. Participants will 
also participate in a quality of life questionnaire before and after RT. 
 
2. Background: 
 
RD is a common and often debilitating adverse event associated with the use of 
fractionated external beam RT for the treatment of numerous cancers. RD may occur 
within hours to weeks of exposure to radiation and often worsens throughout the course 
of treatment.1 Symptoms include itching and pain which can severely affect quality of life.2 
RD occurs in up to 95% of patients who receive RT for curative cancer treatment and 
rates are highest amongst patients treated for breast, head and neck, and anogenital 
cancers.3 The most commonly used grading instrument for RD, the Common Terminology 
Criteria for Adverse Events (the CTCAE), grades RD on a scale of 0-5, with higher grades 
indicating more severe involvement as seen in figure 1.4  
Direct damage to keratinocytes in addition to local inflammation are proposed to 
cause RD, however the pathogenesis of the subsequent inflammation is not well 
understood.  One proposition is that bacteria on the skin may increase the risk of severe 
RD by increasing inflammation and preventing the natural re-epithelialization of the 
keratinocytes exposed to radiation.5 Several case reports have shown that secondary 
infection with bacteria such as Staphylococcus Aureus (SA) has been implicated in RD, 
and they propose that bacteria exacerbates dermatitis via activation of MHC class II 
molecules on immune cells.1 The association between SA infection and RD was also 
confirmed in a small study which found that 23% of RD patients had secondary skin 
infections and that a large subset of those patients (57%) developed grade 4 RD.6  
In a recent study, our group discovered that nasal colonization with any bacteria 
and specifically with SA prior to RT was a powerful predictor of high-grade RD. Further 
supporting the role of bacteria in the pathogenesis of RD, we found more SA on the 
radiated skin after treatment in patients with high grade RD. These findings were 
consistent with similar results in other inflammatory skin diseases such as atopic 
dermatitis and mycosis fungoides, where SA has been shown to play an important role in 
skin inflammation.7,8 Prior studies have not looked at bacterial decolonization as a 
strategy to prevent RD. The goal of this study is to assess the efficacy of bacterial 
decolonization in patients prior to and during RT. The study outcomes have the potential 
to change the way we approach prevention of RD in cancer patients. 
Universal bacterial decolonization using similar strategies to what we are 
proposing have been shown to be safe and cost effective in other disease states, and is 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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now the standard of care in the intensive care unit and prior to orthopedic surgery in order 
to prevent infectious complications. For example, Huang et al found that universal SA 
decolonization with chlorhexidine and mupirocin dramatically decreased methicillin 
resistant 
staphylococcus 
aureus 
(MRSA) 
prevalence 
and 
MRSA-associated 
hospitalizations in a county-wide study.9 A recent systematic review of 19 studies showed 
that there was a reduction in surgical site infections and wound complications after 
institution of a SA screening and decolonization protocol.10  
This study will focus on preventing RD in patients with breast and head/neck 
cancer, as these cancer types are associated with the highest incidence of RD. 
Anogenital cancers will not be included in this study, as too few patients from this category 
were recruited in our preliminary study to achieve statistical significance. Furthermore, 
this study excludes patients receiving RT for palliative intent as these patients receive few 
treatments and are unlikely to develop radiation dermatitis. By implementing a similar 
decolonization protocol in patients receiving RT, we hope to prevent the development of 
RD and improve quality of life.  
3. Objectives and endpoints: 
1. The primary goal is to determine if bacterial decolonization prior to RT prevents 
development of high grade RD (grade 2-5). The primary endpoint is the incidence 
of high grade RD at the end of the trial. 
2. The secondary goal is to assess if the intervention improves quality of life 
compared to the control arm. The secondary endpoint is the quality of life, 
assessed by the Skindex-16. 
4. Study Design: 
 
4.1 Subject inclusion criteria: 
1. Age ≥ 18 
2. Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated 
RT (≥ 15 fractions) with curative intent, including post-operative patients deemed 
eligible for RT by their surgeons and radiation oncologists 
 
4.2 Patient exclusion criteria: 
1. Prior RT to the region of interest 
2. Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, 
psoriasis, and non-healing wounds)  
3. Known allergy to chlorhexidine or mupirocin 
 
4.3 Recruitment: 
 
Patients will be recruited from the Montefiore-Einstein Department of Radiation 
Oncology.  Study physicians will identify patients seen in their clinics that meet the study’s 
inclusion criteria.  We aim to recruit up to 80 patients for the study.  Adult patients with 
breast or head and neck cancer receiving curative radiation therapy will be eligible for the 
study. There will be no compensation for the study.  
 
 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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4.4 Study Procedures  
 
This trial will be a randomized controlled trial assessing the efficacy of universal 
bacterial decolonization in preventing high-grade RD. Therefore, all participants, 
regardless of baseline culture results, will be 1:1 randomized to one of two arms: the 
intervention arm and the control arm. The randomization will be performed in a stratified 
manner within each of the two cancer types (breast cancer or head and neck cancer).   
All patients, regardless of treatment arm, will receive a complete history and 
physical exam during their screening visit. Patients in the control arm will be treated 
according to standard of care without any RD prophylaxis. Patients in the intervention arm 
will receive a decolonization regimen, which is accepted as standard of care and 
commonly used in other patient populations (ICU and prior to orthopedic surgery). The 
decolonization regimen will consist of intranasal mupirocin ointment to be applied twice 
daily to the nares and chlorhexidine wash to be used once daily to the body. This 
combined regimen will be conducted by the patient for 5 consecutive days prior to the 
start of RT, and will be repeated for an additional five days every 2 weeks for the duration 
of RT, according to standard of care decolonization methods.9 Should a patient 
experience an adverse reaction to the topical chlorhexidine gluconate solution or 
mupirocin ointment, the principal investigator may discontinue their participation from the 
study and, depending on severity of adverse effect, remove the offending agent and treat 
any resulting rash or skin discomfort. This will not affect their radiation therapy treatment, 
and they will continue to receive standard of care radiation therapy. 
Chlorhexidine and mupirocin will be prescribed by the principal investigator prior 
to the start of radiation therapy, at no cost to the patient. Patients will be supplied with a 
calendar showing the dates of decolonization and asked to document their decolonization 
regimen to monitor for compliance. Standardized photographs of the radiated area will be 
taken at baseline, and at the end of RT for purposes of grading. Should a patient refuse 
photographs, they may still participate in the study. Grading scores from the treating 
radiation oncologist’s note in the electronic health record will be used in place of clinical 
photographs. Research funds from the division of dermatology and radiation oncology will 
be used to pay for bacterial culture swabs, wound culture laboratory fees, mupirocin, and 
chlorhexidine solutions. Should a patient in any treatment arm develop symptomatic RD 
or RD that is grade 2 or higher, the patient will be treated by the radiation oncologist. 
There is no restriction on use of topical or oral antibiotics as needed during the study. 
Patients may be treated by the radiation oncologist with other topical preparations 
including Aquaphor and/or silver sulfadiazine regardless of treatment arm. 
The SKINDEX-16 questionnaire will be used prior to initiation of RT and at 
completion of RT to assess whether decolonization can improve patient quality of life. 
Validated in 2001, this questionnaire assesses domains of symptoms, emotions, and 
functioning. This questionnaire is commonly used in the evaluation of dermatologic 
diseases including RD, as it has demonstrated both content and construct validity in 
previous studies.11 For example, one recent clinical trial that assessed mometasone 
furoate for the prevention of RD in breast cancer patients also utilized the SKINDEX-16 
to assess quality of life as a secondary measure.12 Furthermore, our preliminary study 
showed that patients with more severe RD were impacted more severely than patients 
without RD in all three domains (data submitted for publication). 
Finally, de-identified samples from superficial skin swabs will be placed in a 
storage buffer meant to preserve bacterial nucleotides and kept in a freezer at -80C for 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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future microbiome analysis. Bacterial RNA and DNA will then be extracted from the 
samples in order to perform skin microbiome analysis via whole-community 
metagenomics sequencing and RNA transcriptomics sequencing.  Of note, only bacterial 
samples from culture swabs will be stored for future microbiome analysis of the skin flora. 
No DNA from participants will be stored. 
 
 
Study evaluations will include: 
 
Before RT and within two weeks of completion of RT:  
• Bacterial cultures obtained via a superficial swab from (1) the nares, (2) skin at the 
irradiated site and (3) contralateral or other non-radiated skin. This is a non-
invasive test using a cotton-tipped applicator inserted into the nostrils or rubbed on 
the skin. 
• Superficial swabs from the same 3 sites will be obtained in the same manner to be 
stored in a -80° C freezer for future de-identified microbiome analyses. 
• Standardized photographs of skin at radiated site to be graded by a dermatologist 
blinded to study arm. Additional photographs or notes from the chart may be taken 
in the case of that severe RD develops during treatment. 
• Quality of Life assessment using the Skindex-16 questionnaire.10 
 
Before and during RT: 
• 
Patients will be asked to initial each date on the supplied calendar when they 
complete the decolonization protocol in order to assess compliance.  
 
4.5 Study Calendar and Study Timeline 
 
Study Calendar: 
 
Screening  
Pre-RT     (-5 
days) 
Radiation 
Therapy 
Week 2  
Radiation 
Therapy  
Week 4 
Radiation 
Therapy  
Week 6 (if 
applicable) 
Radiation 
Therapy  
Week 8 (if 
applicable) 
Last day of RT 
or within 2 
weeks of RT 
completion 
Informed Consent 
X 
 
 
 
 
 
 
Complete History 
and Physical 
X 
 
 
 
 
 
X 
Randomization 
X 
 
 
 
 
 
 
Bacterial Culture 
Swabs* 
X 
 
 
 
 
 
X 
Photographs of skin 
at radiated site 
X 
 
 
 
 
 
X 
Skindex-16 
Questionnaire 
X 
 
 
 
 
 
X 
Decolonization 
Regimen 
 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
 
Patient Medication 
Calendar** 
X 
X 
X 
X 
X 
X 
 
 


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* Bacterial cultures obtained via a superficial swab from (1) the nares, (2) skin at the 
irradiated site and (3) contralateral or other non-radiated skin. This is a non-invasive test 
using a cotton-tipped applicator inserted into the nostrils or rubbed on the skin, 
 
** A member of the study team will provide the patient with medication calendars prior to 
the start of each prescribed regimen, and review for compliance throughout treatment. 
Patients will be asked to initial each date on the supplied calendar when they complete 
the decolonization protocol in order to assess compliance.  
 
 
 
Study Timeline: 
 
April 2019- 
April 2020 
April 2020 
- December 
2020 
Subject Enrollment 
X 
 
Data Collection 
X 
X 
Statistical Analysis 
 
X 
Results Reporting 
 
X 
 
 
4.6 Consent 
 
Consent will be performed in the Montefiore-Einstein Center for Cancer Care 
Radiation Oncology clinics. The study PI, co-investigators, and key personnel will all 
participate in providing the informed consent to possible study participants. Study key 
personnel, which includes the treating radiation oncologists, will identify eligible patients. 
These personnel will then explain the study, explain the consent form, ask the patient if 
they have any questions, and confirm that they are willing to participate in the study. 
 
5.1 Statistical Plan and Power Analysis 
 
All analyses will be performed according to intention to treat, where patients are 
analyzed as randomized. The study statistician will conduct randomization and the study 
coordinator will hold the randomization key. Baseline characteristics will be compared 
between the interventional arm and the control arm using 2-sample t-tests for continuous 
variables and using Pearson’s chi square or Fisher’s exact tests for categorical variables. 
Primary endpoint analysis: The primary study endpoint is development of higher grade 
radiation dermatitis (RD) (grade 2-5) compared to lower grade RD (grade 0-1) during the 
course of external beam radiotherapy. While grades 3-5 are normally considered "high-
grade radiation dermatitis,” we will be considering and analyzing grades 2-5 as “higher 
grade radiation dermatitis” versus grades 0-1 as “lower grade dermatitis.” No patients in 
our previous study experienced grades 4-5 radiation dermatitis, so this grouping will be 
performed for ease of statistical analysis.  Pearson’s chi square or Fisher’s exact tests will 
be used to compare the incidence rates of high-grade (grade 2-5) radiation dermatitis 
between the interventional arm and the control arm to assess whether the intervention is 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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associated with a lower incidence rate of high-grade RD. Logistic regression models will 
be used to assess this association while adjusting for covariates including age, gender, 
BMI, cancer type, radiation dose, and concurrent chemotherapy.  
Secondary endpoint analysis: Secondary endpoint, quality of life (QoL), will be 
assessed before and after the radiotherapy. Paired t-tests will be used to compare the 
QoL summary score between baseline and at the end of the trial within each arm. The 2-
sample t-test will be used to compare the QoL score change from baseline to the end of 
radiotherapy between the two arms. Linear regression models will be used to compare 
the changes in QoL scores between the 2 arms while adjusting for covariates including 
age, gender, BMI, cancer type, radiation dose, and concurrent chemotherapy. Missing 
data will be minimized by pre-emptively implementing effective participant follow-up 
strategies and by ensuring optimal data collection. In the subsequent analyses, we will 
evaluate the type and mechanisms of missing data, for example whether it is missing at 
random (MAR). Multiple imputations may be used to impute missing data. Results 
obtained from data with imputation will be compared to those obtained from complete 
data to assess the influence of missing data. Reasons and characteristics of loss-to-
follow-up will be documented and examined in order to assess the extent to which patient 
attrition could bias our results.  
Power Analysis: Based on previous studies, we expect that ~50% of our recruited patients 
will have breast cancer and ~50% will have head/neck cancer. To control for this, we plan 
to randomize patients in a stratified manner, so that 30 patients with each subtype of 
cancer will be recruited into each arm (interventional and control arm). With 30 patients 
in the interventional arm and 30 patients in the control arm, assuming a significance level 
(alpha) of 0.05, the study has 0.80 power to detect a minimum difference of 0.29 in the 
incidence of Grade 2-5 radiation dermatitis between the arms using 2-sided test. The 
sample size was calculated based on results from a previous study from our lab, in which 
the incidence rate of grade 2-3 radiation dermatitis in the control arm was 0.38. Assuming 
a conservative 25% attrition rate in the study, we plan to recruit a total of 80 patients (40 
each arm) in order to ensure a final sample size of 60 (30 each arm). 
 
 
6. Data Monitoring and Safety  
 
 
6.1 Data Storage 
 
Patient data and images will be entered into software on Montefiore clinic computers that 
are password protected where only study investigators and involved physicians will have 
access to the data. Patient identifying information will be recorded to allow for appropriate 
medical chart review, which will be important for the study’s analyses. The clinic’s data 
managers will help oversee that all patient data and information is protected and 
confidential. All patients will receive an identification code that will be kept in a password 
protected excel spreadsheet associated with their MRN. All other patient study 
information will be kept separate from any of their identifying information. 
 
 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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6.2 Confidentiality  
 
Information about study subjects will be kept confidential and managed according  
to the requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Those regulations require a signed subject authorization informing the subject 
of the following: 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI. 
• In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected prior 
to the revocation of subject authorization.  For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission 
to collect at least vital status (i.e. that the subject is alive) at the end of their 
scheduled study period. 
 
6.3 Source Documents  
Source data is all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Source data are contained in source documents.   Examples of these original documents, 
and data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after 
verification as being accurate and complete, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at 
the laboratories, and at medico-technical departments involved in the clinical trial. 
 
6.4 Adverse Event Monitoring and Reporting 
 
As this is an interventional protocol, any adverse events will be recorded and 
reported. Both mupirocin and chlorhexidine are topical medications that are routinely used 
in the hospital setting, therefore few adverse events are expected. Because this is small 
single site study with no more than minimal risk expected, the study principle investigator 
(PI) will monitor closely for adverse events. The treating radiation oncologist will assess 
for adverse events at each radiotherapy visit as well. Any unanticipated or serious events 
(grade 3 or higher) related to participation in this study will be investigated by the study 
PI and reported to the Einstein IRB.  All adverse events will be recorded in an electronic 
document that is de-identified. This adverse events log, attached in the appendix, will 
then be submitted to the IRB at the time of protocol renewal. 
 
Unanticipated problems, defined by the Office for Human Research Protections (OHRP) 
include any incident, experience, or outcome that meets all of the following criteria: 
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the subject 
population being studied; 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
 10 
2. Related or possibly related to participation in the research (in this guidance 
document, possibly related means there is a reasonable possibility that the incident, 
experience, or outcome may have been caused by the procedures involved in the 
research); and 
3. Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
Any incident that meets all three criteria will be reported study and clinic staff to the 
Principle Investigator within 48 hours.  All serious events related to study participation 
and death among participants will be reported to the Einstein IRB via: 
 
Phone: 718.430.2237 
Email: irb@einstein.yu.edu    
 
Events that require reporting will be graded according to the CTCAE version 5.0.  All study 
related clinic sites have access to this form and it can be downloaded at 
http://ctep.cancer.gov. 
 
Already in place in and distinct from the study, all safety monitor and reporting will be 
done by the standard of care and protocols of the Montefiore Center for Cancer Care and 
department of radiation oncology. There will be no Data Monitoring Committee.  Any 
serious events will be reported to both the study PI and IRB. 
 
The study PI, co-investigators and key personnel will be charged with assuring data 
accuracy and protocol compliance, interim monitoring of accumulated data from research 
activities to assure the continuing safety of participants, relevance of the study question, 
appropriateness of the study, and integrity of the accumulating data. 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. Appendix  
Figure 1. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for 
Radiation Dermatitis  


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
 11 
Injury, poisoning and procedural complications 
CTCE Term 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
Dermatitis 
radiation 
Faint erythema 
or dry 
desquamation 
Moderate to 
brisk erythema; 
patchy moist 
desquamation; 
mostly confined 
to skin folds and 
creases; 
moderate 
erythema 
Moist 
desquamation 
in areas other 
than skin folds 
and creases; 
bleeding 
induced by 
minor trauma or 
abrasion 
Life-threatening 
consequences; 
skin necrosis or 
ulceration of full 
thickness 
dermis; 
spontaneous 
bleeding from 
involved site; 
skin graft 
indicated 
Death 
*Dermatitis Radiation Definition: A finding of cutaneous inflammatory reaction occurring as a 
result of exposure to biologically effective doses of ionizing radiation 
*Navigational Note: Synonym: Radiation induced skin toxicities (CTCAE v3.0) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Skindex-16  


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Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
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Figure 3. Blank Study Calendar 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
 14 
Figure 4. Patient Instructions 
 
Bath Instructions 
Shower or bathe with chlorhexidine (CHG) for 5 days in a row, beginning five days before 
your first radiation therapy session. Repeat for five days in a row, Monday-Friday, every 
2 weeks for the duration of your treatment.  
1. With each shower or bath, wash your hair as usual first with your regular shampoo. 
Do not use your regular shampoo after applying chlorhexidine. 
2. Rinse your hair and body thoroughly after you shampoo your hair to remove the 
shampoo residue.  
3. Apply the chlorhexidine (CHG) soap to your entire body ONLY FROM THE NECK 
DOWN. Do not use chlorhexidine (CHG) near your eyes or ears to avoid 
permanent injury to those areas. Do NOT apply chlorhexidine soap to deep, open 
wounds. 
4. Turn water off and begin applying chlorhexidine soap. For the best effect, try to 
keep the chlorhexidine soap on skin as long as possible (2 minutes if you can) 
before rinsing off. While washing, 
a. Please pay special attention to the neck, armpit, groin, areas between the 
fingers and toes, and all skin folds, including under the breasts for women 
b. FIRMLY MASSAGE soapy sponge onto the areas below before placing 
back into the water   
ü Arms & Legs 
ü Chest & Back 
ü Abdomen 
ü Hip & Groin, then genitals & buttocks last 
1. Turn the water back on and rinse your body thoroughly.  
2. Reapply soap a SECOND TIME to all skin areas from the neck down by 
FIRMLY MASSAGING as above.  
3. Rinse after 2 minutes and pat dry with a towel. 
 
 
Allergic reactions and skin reactions are rare, but can occur.  If you develop a rash or skin 
irritation that you believe is due to the chlorhexidine, discontinue use and contact our 
study staff at roya.nazarian@icahn.mssm.edu.  We encourage you to contact us if you 
are unsure and would like to discuss concerns with study staff. 
Severe allergic reactions are very rare, but can occur. If you develop an allergic 
reaction involving severe hives or have any difficulty breathing, call 911 or go to your 
nearest emergency department. 
 
 
 
 
 


Bacterial Decolonization RCT and QOL Study Protocol Version 1 12.31.18 
 15 
Mupirocin Nasal Ointment Instructions 
  
Apply mupirocin ointment to nostrils twice daily for 5 days in a row. Repeat this 5-day course 
every 2 weeks, Monday-Friday, for the duration of your radiation therapy. 
1. Wash hands prior to application of mupirocin ointment. 
2. Apply a fingertip’s length amount of ointment, as shown below, to a Q-tip. 
 
3. Apply the Q-tip to the inside of both nostrils. Take care not to insert the Q-tip too far 
into your nostrils. 
4. Close your nostrils by pressing the sides of the nose together and then releasing them. 
Do this over and over again for approximately 1 minute. You may also press the sides 
of the nose together and gently massage the nose.  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 5. Adverse Event Log 
IRB #: 
PI Name: 
Subj
ect 
ID# 
Dat
e of 
Ons
et 
Date 
Resolv
ed 
Outco
me* 
Serio
us- 
ness*
* 
Relati
on- 
ship*** 
Unanticip
ated (Y/N) 
Action 
with 
Study 
Treatment
**** 
Reporta
ble 
to 
Sponsor 
(Y/N) 
Date 
Sent 
to 
Spons
or 
Reporta
ble 
to IRB 
(Y/N) 
Dat
e 
Se
nt 
to 
IR
B 
PI 
Initia
ls 
and 
date 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Event Description: 
 
Key 
*Outcome 
1. Resolved 
2. Resolved with sequelae 
3. Recovering 
4. Not Recovered/Not Resolved 
5. Fatal 
6. Unknown 
**Seriousness 
1. Fatal 
2. Life-threatening 
3. Serious 
4. Not Serious 
***Relationship 
1. Definite 
2. Probable 
3. Possible 
4. Unlikely 
****Action with Study Treatment 
1. No Action 
2. Interrupted 
3. Discontinued 
 
 
 
 
 
 


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8. References 
 
1. 
Hill A, Hanson M, Bogle MA, Duvic M. Severe radiation dermatitis is related to 
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