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Preventative Skin Care for Pediatric Brain Cancer

Phase 2

Waitlist Available

Led By Jennifer Huang, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, Targeted MEK inhibitor therapy, Targeted pan-RAF inhibitor therapy

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing a skin care routine to see if it can prevent side effects in children with brain tumors who are taking MEK, Pan-RAF, or BRAF inhibitors.

Who is the study for?

This trial is for children aged 6 months to 18 years with a brain tumor, who will be treated with specific targeted therapies (BRAF, MEK, or pan-RAF inhibitors). They must be able to follow a skin care routine including sun protection and bleach baths. Children with allergies to sunscreen or skincare products used in the study cannot participate.Check my eligibility

What is being tested?

The study tests whether a preventive skin care regimen can help children undergoing treatment for brain tumors with certain inhibitors. The regimen includes dilute bleach baths, high SPF sunscreen, moisturizers, protective clothing, and limited sun exposure.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the bleach baths or allergic reactions to the skincare products like sunscreen and moisturizers. Sunscreen might also cause discomfort if there's an existing sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was diagnosed with a brain tumor as a child and will be treated with targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Cutaneous Reaction

Secondary outcome measures

Children's Dermatology Quality of life

Hand foot syndrome Severity

Overall Cutaneous Reaction Severity

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Preventative Skin Care RoutineExperimental Treatment6 Interventions

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,852 Total Patients Enrolled

Jennifer Huang, MD3.04 ReviewsPrincipal Investigator - Boston Children's Hospital

Dana-Farber Cancer Institute

2 Previous Clinical Trials

12 Total Patients Enrolled

1Patient Review

Will give you a severe diagnosis to scare you, make you wait 3 months for an appointment, and then just tell you bug bites. Made my wife feel unintelligent for not being a native English speaker.

Media Library

Dilute bleach baths (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04479514 — Phase 2

Eczema Research Study Groups: Preventative Skin Care Routine

Eczema Clinical Trial 2023: Dilute bleach baths Highlights & Side Effects. Trial Name: NCT04479514 — Phase 2

Dilute bleach baths (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04479514 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any possibility that I could join this trial?

"This medical experiment is looking for 20 volunteers aged 6 months to 18 who present signs of dermatitis. Moreover, interested applicants must demonstrate their ability to adhere to the Prescriber-Sponsored Cutaneous Research protocol (PSCR), including sun protection methods, delicate skin care techniques and intermittent diluted bleach baths. In addition, participants may have had BRAF inhibitor therapy prescribed in relation to a brain tumour or MEK/pan-RAF inhibitors as treatment for said growths. Furthermore, potential recruits are allowed to take part in other clinical studies concurrently with this trial."

Answered by AI

Are participants aged 35 or older eligible for this trial?

"This medical trial is open to all patients between the ages of 6 Months and 18 years old. According to clinicaltrials.gov, there are 251 studies available for minors and 479 specifically designed for individuals over 65 years old."

Answered by AI

Is this research effort currently seeking participants?

"Correct. The clinical trial page hosted on clinicaltrials.gov confirms that recruitment is underway; the study was first posted on October 1st 2020 and most recently edited on January 31st 2022. There are 20 spots across 2 medical centres for participants to enroll in this research."

Answered by AI

To what conditions is a diluted bleach bath commonly prescribed?

"Dilute bleach baths offer a potential remedy for sunburn, pancreatic inadequacy, and chapping."

Answered by AI

Does the FDA endorse dilute bleach baths as a viable treatment option?

"The safety of dilute bleach baths is given a rating score of 2, as there is some evidence in favour of its safety but none regarding efficacy."

Answered by AI

How many participants are being incorporated into this experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting participants who can be found at two different sites of the trial. It was first published on October 1st 2020 and most recently updated January 31st 2022 with 20 people required for the study's completion."

Answered by AI

Are there other research efforts exploring the efficacy of Dilute bleach baths?

"Currently, 12 clinical trials are researching the effects of Dilute bleach baths. Two of those studies have advanced to Phase 3 testing. The majority of these experiments occur in Palo Alto, California; however, there are 231 different sites actively conducting research for this treatment option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Jennifer Huang, MD 2020. "Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479514.

All > Seborrheic Dermatitis > Pediatric Cancer