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Completed

NCT Number: NCT04479514

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

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.

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Key information

Conditions

Pediatric Cancer CNS Tumor, Childhood Central Nervous System Neoplasms Dermatitis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Skin Diseases Skin Inflammation Skin and Connective Tissue Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warm Baths or Showers

Other

Daily warm baths or showers

Moisturizer

Other

moisturizers applied daily immediately after bathing

SPF 30 or Higher Suncreen

Drug

Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.

Other names: i.e. Neutrogena, Aveeno, Cerave, Blue Lizard

Sun Protective Clothing

Other

Sun protective clothing worn when outdoors

Limited Sun Exposure

Behavioral

Limit sun exposure during peak hours of 10am-4pm

Dilute bleach baths

Other

Warm 10-15 minute dilute bleach baths every other day

Primary outcomes

  1. Rate of Cutaneous Reaction

    Time frame: 12 weeks

    Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy

Secondary outcomes

  1. Overall Cutaneous Reaction Severity

    Time frame: 12 weeks

    Measured by the Common Terminology Criteria for Adverse Events (CTCAE), minimum 1 maximum 5 with 5 being the most severe. If patients had a skin reaction, CTCAE was used to gradfe the severity of their reaction. There are no subscales.

  2. Xerosis Incidence

    Time frame: 12 weeks

    Measured by # of participants with xerosis

  3. Hand Foot Syndrome

    Time frame: 12 weeks

    Measured incidence of hand foot syndrome

  4. Children's Dermatology Quality of Life

    Time frame: 12 weeks

    Children's Dermatology Life Quality Index (CDLQI) is used to measure the impact of skin disease on quality of life. The range of scores is from 0-30 with 30 indicating the greatest impact on quality of life. There are no subscales.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 21, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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