Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Therapy and the Natural History of Childhood Cancers

NCT00064883

Cancer Childhood Malignancy

COMPLETED

Study of Systemic and Spinal Chemotherapy Followed by Radiation for Infants With Brain Tumors

NCT00042367

Brain Tumors

COMPLETED NA

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

NCT01175356

Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma +3 more

COMPLETED PHASE1

Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology

NCT02847130

Acute Lymphoblastic Leukemia B-Cell Non-Hodgkin Lymphoma Childhood Acute Myeloid Leukemia +5 more

COMPLETED

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

NCT00002647

Brain and Central Nervous System Tumors Metastatic Cancer

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Cancer CNS Tumor, Childhood Skin Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Warm Baths or Showers

Intervention Type OTHER

Daily warm baths or showers

Moisturizer

Intervention Type OTHER

moisturizers applied daily immediately after bathing

SPF 30 or Higher Suncreen

Intervention Type DRUG

Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.

Sun Protective Clothing

Intervention Type OTHER

Sun protective clothing worn when outdoors

Limited Sun Exposure

Intervention Type BEHAVIORAL

Limit sun exposure during peak hours of 10am-4pm

Dilute bleach baths

Intervention Type OTHER

Warm 10-15 minute dilute bleach baths every other day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Warm Baths or Showers

Daily warm baths or showers

Intervention Type OTHER

Moisturizer

moisturizers applied daily immediately after bathing

Intervention Type OTHER

SPF 30 or Higher Suncreen

Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.

Intervention Type DRUG

Sun Protective Clothing

Sun protective clothing worn when outdoors

Intervention Type OTHER

Limited Sun Exposure

Limit sun exposure during peak hours of 10am-4pm

Intervention Type BEHAVIORAL

Dilute bleach baths

Warm 10-15 minute dilute bleach baths every other day

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

i.e. Neutrogena, Aveeno, Cerave, Blue Lizard

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No