The Impact of Dilute Bleach Compresses on the Incidence and Severity of Radiation Dermatitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
研究概览
简要总结
This study is looking at the safety of applying dilute bleach compresses to patients receiving radiation therapy and the impact of these dilute bleach compresses on the frequency and severity of skin changes that occur during radiation therapy.
The names of the study interventions involved in this study are:
- Di-Dak-Sol: dilute bleach compresses
- White petrolatum ointment
详细描述
This is a planned open-label prospective clinical trial to determine the safety of applying dilute bleach compresses to pediatric patients being treated for rhabdomyosarcoma and other soft tissue and bone sarcomas with radiation therapy (RT).
This study is interested in finding out whether dilute bleach compresses are safe to apply and evaluating their impact on the frequency and severity of skin changes that occur in children who are receiving radiation therapy for cancer treatment.
This information may help treat other patients receiving radiation therapy for cancer treatment in the future.
The research study procedures include screening for eligibility and study treatment including weekly evaluations and follow up visits
Participants will receive study treatment throughout their radiation therapy and for one week after. They will be followed for one month after the completion of radiation.
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
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a rhabdomyosarcoma or other sarcoma requiring RT
- •12 to 25 years of age
- •Scheduled for a RT planning session (CT simulation)
- •Have a scheduled RT start date within 1 to 2 weeks from the CT simulation
- •Will be receiving doses of radiotherapy greater than at least 36 Gy
- •Subjects may participate in other studies, including therapeutic trials.
- •Ability to comply with at-home dilute Di-Dak-Sol compresses for final week of dilute Di-Dak-Sol compresses following radiation treatment.
- •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
- •Patients who are pregnant, which may result in discontinuation of RT
- •Presence of inflammatory skin lesions in the radiation field that could interfere with assessment
研究组 & 干预措施
Di-Dak-Sol + White Petrolatum
Participants will receive Di-Dak-Sol (dilute bleach compresses) prior to receiving radiation. This will continue throughout their radiation therapy and for one week after.
Participants will also be asked to apply white petrolatum ointment 2x daily throughout treatment: once after radiation and once in the evening.
Participants will be provided with a log and asked to document information (dates/times of application) about the study treatment .
干预措施: Di-Dak-Sol (Drug)
Di-Dak-Sol + White Petrolatum
Participants will receive Di-Dak-Sol (dilute bleach compresses) prior to receiving radiation. This will continue throughout their radiation therapy and for one week after.
Participants will also be asked to apply white petrolatum ointment 2x daily throughout treatment: once after radiation and once in the evening.
Participants will be provided with a log and asked to document information (dates/times of application) about the study treatment .
干预措施: White Petrolatum (Other)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
时间窗: 1 year
The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.
次要结局
- Number of Participants with Radiation dermatitis(1 year)
研究者
Jennifer Huang, MD
Principal Investigator
Dana-Farber Cancer Institute