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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04479514
Other study ID # 19-579
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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