Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2020
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2025
CompletedResults Posted
Study results publicly available
May 1, 2025
CompletedMay 1, 2025
April 1, 2025
3.3 years
July 15, 2020
April 15, 2025
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Overall Cutaneous Reaction Severity
12 weeks
Xerosis Severity
12 weeks
Hand Foot Syndrome Severity
12 weeks
Pediatric Quality of Life
12 weeks
Children's Dermatology Quality of Life
12 weeks
Study Arms (1)
Preventative Skin Care Routine
EXPERIMENTALParticipants 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
Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
Sun protective clothing worn when outdoors
Limit sun exposure during peak hours of 10am-4pm
Warm 10-15 minute dilute bleach baths every other day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Huang
- Organization
- DFCI
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Huang, MD
Boston Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 15, 2020
First Posted
July 21, 2020
Study Start
October 1, 2020
Primary Completion
January 1, 2024
Study Completion
February 15, 2025
Last Updated
May 1, 2025
Results First Posted
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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.