Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Pediatric Cancer Clinical Trial

Official title:

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04479514
• Other study ID #: 19-579
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Tumor, Childhood
• Dermatitis
• Inflammation
• Pediatric Cancer
• Skin Inflammation

Intervention

Other:
• Warm Baths or Showers
Daily warm baths or showers
• Moisturizer
moisturizers applied daily immediately after bathing

Drug:
• SPF 30 or Higher Suncreen
Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.

Other:
• Sun Protective Clothing
Sun protective clothing worn when outdoors

Behavioral:
• Limited Sun Exposure
Limit sun exposure during peak hours of 10am-4pm

Other:
• Dilute bleach baths
Warm 10-15 minute dilute bleach baths every other day

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

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