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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Cancer; Skin Inflammation; CNS Tumor, Childhood
• Intervention / Treatment: 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

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
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jennifer Huang, MD; Phone Number: 617-355-1477; Email: Jennifer.Huang@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jennifer Huang, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric Cancer; CNS Tumor, Childhood; Skin Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Inflammation; Dermatitis; Central Nervous System Neoplasms
• Other Study ID Numbers: 19-579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• 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