Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Rate of Cutaneous Reaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Warm Baths or Showers (Other)
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.
干预措施: Moisturizer (Other)
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.
干预措施: SPF 30 or Higher Suncreen (Drug)
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.
干预措施: Sun Protective Clothing (Other)
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.
干预措施: Limited Sun Exposure (Behavioral)
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.
干预措施: Dilute bleach baths (Other)
结局指标
主要结局
Rate of Cutaneous Reaction
时间窗: 12 weeks
Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
次要结局
- Overall Cutaneous Reaction Severity(12 weeks)
- Xerosis Severity(12 weeks)
- Hand Foot Syndrome Severity(12 weeks)
- Pediatric Quality of Life(12 weeks)
- Children's Dermatology Quality of Life(12 weeks)
研究者
Jennifer Huang, MD
Principal Investigator
Dana-Farber Cancer Institute