Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Skin Inflammation

CNS Tumor, Childhood

Pediatric Cancer

Treatments

Other: Sun Protective Clothing

Behavioral: Limited Sun Exposure

Other: Dilute bleach baths

Other: Moisturizer

Drug: SPF 30 or Higher Suncreen

Other: Warm Baths or Showers

Study type

Interventional

Funder types

Other

Identifiers

NCT04479514

19-579

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Preventative Skin Care Routine

Experimental group

Description:

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.