Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
Conditions
Keywords
Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation
Brief 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.
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.
Interventions
OTHERWarm Baths or Showers
Daily warm baths or showers
OTHERMoisturizer
moisturizers applied daily immediately after bathing
DRUGSPF 30 or Higher Suncreen
Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
OTHERSun Protective Clothing
Sun protective clothing worn when outdoors
BEHAVIORALLimited Sun Exposure
Limit sun exposure during peak hours of 10am-4pm
OTHERDilute bleach baths
Warm 10-15 minute dilute bleach baths every other day
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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: 1. Targeted BRAF inhibitor therapy to treat the brain tumor 2. Targeted MEK inhibitor therapy to treat the brain tumor 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Cutaneous Reaction | 12 weeks | Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Xerosis Severity | 12 weeks | Measured by the Overall Dry Skin Score (ODS) |
| Overall Cutaneous Reaction Severity | 12 weeks | Measured by the Common Terminology Criteria for Adverse Events (CTCAE) |
| Hand Foot Syndrome Severity | 12 weeks | Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14) |
| Pediatric Quality of Life | 12 weeks | Pediatric Quality of Life Inventory (PedsQL) |
| Children's Dermatology Quality of Life | 12 weeks | Children's Dermatology Life Quality Index (CDLQI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Preventative Skin Care Routine |
|---|---|
| Age, Categorical <=18 years | 13 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 10.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Canada | 7 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Rate of Cutaneous Reaction
Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preventative Skin Care Routine | Rate of Cutaneous Reaction | 7 Participants |
Secondary
Children's Dermatology Quality of Life
Children's Dermatology Life Quality Index (CDLQI)
Time frame: 12 weeks
Secondary
Hand Foot Syndrome Severity
Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
Time frame: 12 weeks
Secondary
Overall Cutaneous Reaction Severity
Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 12 weeks
Secondary
Pediatric Quality of Life
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 12 weeks
Secondary
Xerosis Severity
Measured by the Overall Dry Skin Score (ODS)
Time frame: 12 weeks