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.
Conditions
Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
Recruitment Status
Active, not recruiting
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:
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
Intervention
Intervention Type
Intervention Name
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
Phase
Phase 2
Gender
All
Min Age
6 Months
Max Age
18 Years
Download Date
February 28, 2024
Principal Investigator
Jennifer Huang, MD
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: