Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Phase 2

Completed

• Conditions: Skin Inflammation; Pediatric Cancer; CNS Tumor, Childhood
• Interventions: 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

• Registration Number: NCT04479514
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2020-10-01
• Primary Completion: 2024-01-01
• Study Completion: 2025-02-15
• Status Verified: 2025-04
• Results First Submitted: 2025-04-15
• Results First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Results First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preventative Skin Care Routine	Dilute bleach baths	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.
Preventative Skin Care Routine	Warm Baths or Showers	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.
Preventative Skin Care Routine	Moisturizer	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.
Preventative Skin Care Routine	SPF 30 or Higher Suncreen	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.
Preventative Skin Care Routine	Limited Sun Exposure	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.
Preventative Skin Care Routine	Sun Protective Clothing	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Cutaneous Reaction Severity	12 weeks	Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
Xerosis Severity	12 weeks	Measured by the Overall Dry Skin Score (ODS)
Hand Foot Syndrome Severity	12 weeks	Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
Pediatric Quality of Life	12 weeks	Pediatric Quality of Life Inventory (PedsQL)
Children's Dermatology Quality of Life	12 weeks	Children's Dermatology Life Quality Index (CDLQI)

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States