Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
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| ClinicalTrials.gov Identifier: NCT04479514 |
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Recruitment Status :
Active, not recruiting
First Posted : July 21, 2020
Last Update Posted : February 28, 2024
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| 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 |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | October 1, 2020 |
| Actual Primary Completion Date : | January 1, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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 Name: 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 |
- 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
- Overall Cutaneous Reaction Severity [ Time Frame: 12 weeks ]Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
- Xerosis Severity [ Time Frame: 12 weeks ]Measured by the Overall Dry Skin Score (ODS)
- Hand foot syndrome Severity [ Time Frame: 12 weeks ]Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
- Pediatric Quality of life [ Time Frame: 12 weeks ]Pediatric Quality of Life Inventory (PedsQL)
- Children's Dermatology Quality of life [ Time Frame: 12 weeks ]Children's Dermatology Life Quality Index (CDLQI)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479514
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Jennifer Huang, MD | Boston Children's Hospital |
| Responsible Party: | Jennifer Huang, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT04479514 |
| Other Study ID Numbers: |
19-579 |
| First Posted: | July 21, 2020 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
| Access Criteria: | Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Pediatric Cancer CNS Tumor, Childhood Skin Inflammation |
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Central Nervous System Neoplasms Dermatitis Inflammation Neoplasms Pathologic Processes |
Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases |