Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04479514

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer CNS Tumor, Childhood Skin Inflammation	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	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Huang, MD, Principal Investigator, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT04479514

Other Study ID Numbers:

19-579

First Posted:

Jul 21, 2020

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Jennifer Huang, MD, Principal Investigator, Dana-Farber Cancer Institute

Pediatric Cancer

CNS Tumor, Childhood

Skin Inflammation

Additional relevant MeSH terms:

Central Nervous System Neoplasms

Dermatitis

Inflammation

Study Results

No Results Posted as of Feb 2, 2022