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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm Baths or Showers | Other | Daily warm baths or showers |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cutaneous Reaction | Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Xerosis Incidence |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Huang, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 |
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| Moisturizer |
| Other |
moisturizers applied daily immediately after bathing |
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| SPF 30 or Higher Suncreen | Drug | Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. |
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| Sun Protective Clothing | Other | Sun protective clothing worn when outdoors |
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| Limited Sun Exposure | Behavioral | Limit sun exposure during peak hours of 10am-4pm |
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| Dilute bleach baths | Other | Warm 10-15 minute dilute bleach baths every other day |
|
Measured by # of participants with xerosis |
| 12 weeks |
| Hand Foot Syndrome | Measured incidence of hand foot syndrome | 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. | 12 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Cutaneous Reaction | Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy | Posted | Count of Participants | Participants | 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Xerosis Incidence | Measured by # of participants with xerosis | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Hand Foot Syndrome | Measured incidence of hand foot syndrome | Posted | Count of Participants | Participants | 12 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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12 week period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Huang | DFCI | 6173558937 | jennifer.huang@childrens.harvard.edu |
| Apr 15, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2021 | Apr 15, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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