search
Back to results

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Primary Purpose

Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Warm Baths or Showers
Moisturizer
SPF 30 or Higher Suncreen
Sun Protective Clothing
Limited Sun Exposure
Dilute bleach baths
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Cancer focused on measuring Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preventative Skin Care Routine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2020
Last Updated
February 8, 2023
Sponsor
Dana-Farber Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04479514
Brief Title
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Official Title
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
Keywords
Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preventative Skin Care Routine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Warm Baths or Showers
Intervention Description
Daily warm baths or showers
Intervention Type
Other
Intervention Name(s)
Moisturizer
Intervention Description
moisturizers applied daily immediately after bathing
Intervention Type
Drug
Intervention Name(s)
SPF 30 or Higher Suncreen
Other Intervention Name(s)
i.e. Neutrogena, Aveeno, Cerave, Blue Lizard
Intervention Description
Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
Intervention Type
Other
Intervention Name(s)
Sun Protective Clothing
Intervention Description
Sun protective clothing worn when outdoors
Intervention Type
Behavioral
Intervention Name(s)
Limited Sun Exposure
Intervention Description
Limit sun exposure during peak hours of 10am-4pm
Intervention Type
Other
Intervention Name(s)
Dilute bleach baths
Intervention Description
Warm 10-15 minute dilute bleach baths every other day
Primary Outcome Measure Information:
Title
Rate of Cutaneous Reaction
Description
Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall Cutaneous Reaction Severity
Description
Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
12 weeks
Title
Xerosis Severity
Description
Measured by the Overall Dry Skin Score (ODS)
Time Frame
12 weeks
Title
Hand foot syndrome Severity
Description
Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
Time Frame
12 weeks
Title
Pediatric Quality of life
Description
Pediatric Quality of Life Inventory (PedsQL)
Time Frame
12 weeks
Title
Children's Dermatology Quality of life
Description
Children's Dermatology Life Quality Index (CDLQI)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Huang, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

We'll reach out to this number within 24 hrs