Pediatric CancerPhase 2NCT04479514
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
A Phase 2 study testing Warm Baths or Showers, Moisturizer and SPF 30 or Higher Suncreen in people with Pediatric Cancer and CNS Tumor, Childhood, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
- What is being tested?
- Warm Baths or Showers, Moisturizer and SPF 30 or Higher Suncreen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 15 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
- Being tested
- Warm Baths or Showers, Moisturizer, SPF 30 or Higher Suncreen, Sun Protective Clothing, Limited Sun Exposure
- Keywords
- Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
- Medical subject headings
- Neoplasms, Central Nervous System Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Baths or ShowersOther
Daily warm baths or showers
MoisturizerOther
moisturizers applied daily immediately after bathing
SPF 30 or Higher SuncreenDrug
Also called i.e. Neutrogena, Aveeno, Cerave, Blue Lizard
Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
Sun Protective ClothingOther
Sun protective clothing worn when outdoors
Limited Sun ExposureBehavioural
Limit sun exposure during peak hours of 10am-4pm
Dilute bleach bathsOther
Warm 10-15 minute dilute bleach baths every other day
| Study group | Role | What they receive |
|---|---|---|
| Preventative Skin Care Routine | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cutaneous Reaction
Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
Measured: 12 weeks
Secondary outcomes (4)
Overall Cutaneous Reaction Severity
Measured by the Common Terminology Criteria for Adverse Events (CTCAE), minimum 1 maximum 5 with 5 being the most severe. If patients had a skin reaction, CTCAE was used to gradfe the severity of their reaction. There are no subscales.
Measured: 12 weeks
Xerosis Incidence
Measured by # of participants with xerosis
Measured: 12 weeks
Hand Foot Syndrome
Measured incidence of hand foot syndrome
Measured: 12 weeks
Children's Dermatology Quality of Life
Children's Dermatology Life Quality Index (CDLQI) is used to measure the impact of skin disease on quality of life. The range of scores is from 0-30 with 30 indicating the greatest impact on quality of life. There are no subscales.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Oct 2020
- Primary completion1 Jan 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Huang, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer Huang, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479514
- Sponsor's protocol ID
- 19-579
- Status last verified
- May 2026
- First submitted
- 15 Jul 2020
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
- ClinicalTrials.gov ID
- NCT04479514
- Acronym / sponsor ID
- 19-579
- Conditions
- Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
- Keywords
- Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preventative Skin Care Routine | Experimental | Other: Warm Baths or Showers, Other: Moisturizer, Drug: SPF 30 or Higher Suncreen, Other: Sun Protective Clothing, Behavioral: Limited Sun Exposure, Other: Dilute bleach bathsParticipants 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 may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosed with a brain tumor between ages 6 months old -18 years old and will undergo treatment with at least one of the following:
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Baths or ShowersDaily warm baths or showers | Other | Preventative Skin Care Routine |
| Moisturizermoisturizers applied daily immediately after bathing | Other | Preventative Skin Care Routine |
| SPF 30 or Higher SuncreenAlso: i.e. Neutrogena, Aveeno, Cerave, Blue LizardMineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. | Drug | Preventative Skin Care Routine |
| Sun Protective ClothingSun protective clothing worn when outdoors | Other | Preventative Skin Care Routine |
| Limited Sun ExposureLimit sun exposure during peak hours of 10am-4pm | Behavioural | Preventative Skin Care Routine |
| Dilute bleach bathsWarm 10-15 minute dilute bleach baths every other day | Other | Preventative Skin Care Routine |
Primary outcome
Rate of Cutaneous Reaction
Time frame: 12 weeks
Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
4 secondary outcomes
Overall Cutaneous Reaction Severity
Time frame: 12 weeks
Xerosis Incidence
Time frame: 12 weeks
Hand Foot Syndrome
Time frame: 12 weeks
Children's Dermatology Quality of Life
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Huang, MD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Warm Baths or Showers, Moisturizer and SPF 30 or Higher Suncreen in people with Pediatric Cancer and CNS Tumor, Childhood, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Cutaneous Reaction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.