Preventative Skin Care for Pediatric Brain Cancer

No longer recruiting at 1 trial location

Overseen By Jennifer Huang, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: BRAF, MEK, Pan-RAF inhibitors

Disqualifiers: Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a skin care routine to prevent skin issues in children receiving specific anti-cancer treatments for brain tumors. The routine includes gentle skin care products, daily sun protection, and dilute bleach baths (a type of antiseptic bath) every other day. It is designed for children diagnosed with a brain tumor and undergoing treatment with targeted therapies like BRAF, MEK, or pan-RAF inhibitors. Children who can follow this routine and have no history of allergic reactions to the products used might be suitable for this study. Participants will have their skin checked and complete a survey throughout the trial to assess the routine's effectiveness. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on skin care for children receiving specific cancer treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that using dilute bleach baths is safe and effective for reducing skin bacteria in children. The study recommended a specific amount of bleach, and no participants stopped due to side effects.

For sun exposure, while no direct safety concerns exist, it is important to balance sunlight intake with skin protection from harmful UV rays. Sun protection, such as sunscreen and protective clothing, can prevent skin damage. High SPF sunscreens, like SPF 30, are safe and block 97% of UVB rays, reducing the risk of sunburn.

Warm baths or showers are generally safe if the water is not too hot. Using warm water helps avoid skin irritation.

Overall, these treatments are well-tolerated in children, with proven methods for safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the preventative skin care routine for pediatric brain cancer patients because it offers a novel approach to managing skin health during treatment. Unlike traditional methods that primarily focus on treating existing skin conditions, this routine emphasizes prevention through daily sun protection, gentle skin care, and every-other-day dilute bleach baths. This proactive strategy is designed to maintain skin integrity and potentially reduce skin complications associated with cancer treatments. By focusing on prevention rather than just treatment, the researchers hope to improve the quality of life for young patients undergoing cancer therapy.

What evidence suggests that this preventative skin care routine is effective for pediatric brain cancer patients?

This trial will evaluate a preventative skin care routine for pediatric brain cancer patients. Research has shown that baths with a small amount of bleach can reduce skin damage during cancer treatments. These baths lessen skin irritation and aid healing in children with conditions like dermatitis. Studies also suggest that keeping children out of the sun prevents further skin damage, as sun exposure is a major cause of skin problems. Sunscreen with SPF 30 or higher provides strong protection against harmful UV rays, which can harm sensitive skin. Moisturizers maintain skin health by keeping it hydrated and acting as a protective barrier. Warm baths or showers can soothe the skin and make treatment more comfortable. Participants in this trial will follow this comprehensive skin care routine to assess its effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

Jennifer Huang, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can follow skin care rules including sun protection and bleach baths.

Subjects may participate in other studies, including therapeutic trials

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

Exclusion Criteria

You have had allergic reactions to sunscreen or skin creams that will be used in this study.

You have had an allergic reaction to bleach in the past.

I have been treated with a BRAF, MEK, or pan-RAF inhibitor recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a preventative skin care regimen including daily sun protection, daily gentle skin care, and every-other-day dilute bleach baths during their anti-cancer treatment

12 weeks

3 visits (in-person) at start, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dilute bleach baths
• Limited Sun Exposure
• Moisturizer
• SPF 30 or Higher Suncreen
• Sun Protective Clothing
• Warm Baths or Showers

Trial Overview 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.

How Is the Trial Designed?

Group I: Preventative Skin Care Routine Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04479514

Preventative Skin Care for Children Undergoing Targeted ... ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5726436/

Efficacy of bleach baths in reducing severity of atopic ... In one study at 12-weeks, bleach baths caused significant reductions in EASI and BSA, but not IGA. Across all five studies at all follow-up ...

3. pedraresearch.org pedraresearch.org/2020/01/14/dilute-bleach-compresses-to-reduce-the-severity-of-radiation-dermatitis-in-children-with-cancer/

Dilute bleach compresses to reduce the severity of ... Many years ago, we were able to show that dilute bleach baths reduce the severity of pediatric atopic dermatitis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615920/

Bleach baths enhance skin barrier, reduce itch but do not ... Wong et al. found a significant reduction in itch by visual analog scale in AD subjects after two months of treatment with bleach baths, however ...

5. med.stanford.edu med.stanford.edu/news/insights/2013/11/dilute-bleach-solution-may-combat-skin-damage-and-aging-according-to-stanford-study.html

Dilute bleach solution may combat skin damage and aging ... They found that animals bathed in the bleach experienced less severe skin damage and better healing and hair regrowth after radiation, and the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24111816/

Efficacy and safety of sodium hypochlorite (bleach) baths in ... This study demonstrates that diluted bleach baths clinically improved AD in as little as 1 month. No patient withdrew from the treatment arm because of ...

7. rch.org.au rch.org.au/kidsinfo/fact_sheets/skin_infections_bleach_baths/

Kids Health Info : Skin infections – bleach baths Diluted bleach baths are safe and effective in reducing bacteria on the skin. Add 12 mL of bleach per 10 litres of bath water. Do not rinse the skin after a ...

8. medicalnewstoday.com medicalnewstoday.com/articles/323417

Bleach bath for eczema: Benefits, side effects, tips, and ... The researchers concluded that, in people with moderate to severe AD, bleach baths may improve the severity of AD symptoms by 22%. One in ten ...

9. pedsnw.net pedsnw.net/wp-content/uploads/aph-52-dilute-bleach-baths-form.pdf

Dilute Bleach Baths Bleach that is not very watered down (diluted) is a dangerous household poison. • Never use undiluted bleach directly on the skin. • Avoid getting dilute bleach ...