Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

• ClinicalTrials.gov Identifier: NCT04479514
• Recruitment Status: Active, not recruiting
• First Posted: July 21, 2020
• Last Update Posted: February 28, 2024
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Jennifer Huang, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: July 15, 2020
• First Posted Date: July 21, 2020
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 20, 2020)

• Overall Cutaneous Reaction Severity [ Time Frame: 12 weeks ]
  Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
• Xerosis Severity [ Time Frame: 12 weeks ]
  Measured by the Overall Dry Skin Score (ODS)
• Hand foot syndrome Severity [ Time Frame: 12 weeks ]
  Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
• Pediatric Quality of life [ Time Frame: 12 weeks ]
  Pediatric Quality of Life Inventory (PedsQL)
• Children's Dermatology Quality of life [ Time Frame: 12 weeks ]
  Children's Dermatology Life Quality Index (CDLQI)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
• Official Title: Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Pediatric Cancer
• CNS Tumor, Childhood
• Skin Inflammation

Intervention

• Other: Warm Baths or Showers
  Daily warm baths or showers
• Other: 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 Name: i.e. Neutrogena, Aveeno, Cerave, Blue Lizard
• 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

Study Arms

Experimental: Preventative Skin Care Routine

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.

Interventions:

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 20, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

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:

  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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04479514
• Other Study ID Numbers: 19-579
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

• Current Responsible Party: Jennifer Huang, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jennifer Huang, MD; Boston Children's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: February 2024