Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Conditions
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Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation

Intervention / Treatment
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* Other: Warm Baths or Showers
* Other: Moisturizer
* Drug: SPF 30 or Higher Suncreen
* Other: Sun Protective Clothing
* Behavioral: Limited Sun Exposure
* Other: Dilute bleach baths


Participation Criteria
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Eligibility Criteria
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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: Targeted BRAF inhibitor therapy to treat the brain tumor Targeted MEK inhibitor therapy to treat the brain tumor 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventative Skin Care Routine<br>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. | Other: Warm Baths or Showers<br>* Daily warm baths or showers<br>Other: Moisturizer<br>* moisturizers applied daily immediately after bathing<br>Drug: SPF 30 or Higher Suncreen<br>* Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.<br>* Other names: i.e. Neutrogena, Aveeno, Cerave, Blue Lizard;Other: Sun Protective Clothing<br>* Sun protective clothing worn when outdoors<br>Behavioral: Limited Sun Exposure<br>* Limit sun exposure during peak hours of 10am-4pm<br>Other: Dilute bleach baths<br>* Warm 10-15 minute dilute bleach baths every other day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cutaneous Reaction | Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cutaneous Reaction Severity | Measured by the Common Terminology Criteria for Adverse Events (CTCAE) | 12 weeks | 
| Xerosis Severity | Measured by the Overall Dry Skin Score (ODS) | 12 weeks | 
| Hand foot syndrome Severity | Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14) | 12 weeks | 
| Pediatric Quality of life | Pediatric Quality of Life Inventory (PedsQL) | 12 weeks | 
| Children's Dermatology Quality of life | Children's Dermatology Life Quality Index (CDLQI) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation