Pilot Study of Utilizing Topical Sodium Hypochlorite to Ameliorate or Reduce Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Improvement in patient reported outcome measures
研究概览
简要总结
The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.
This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck
- •Are scheduled for a radiation therapy planning session (CT simulation)
- •Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation
- •Are able to comply with the study protocol
排除标准
- •Patients who are pregnant, which may lead to discontinuation of radiation therapy
- •Patients currently on immunotherapy
- •Active or past history of inflammatory lesions in the radiation field that could interfere with assessment
- •Patients who are undergoing re-irradiation to the head and neck
- •Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
- •Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.
- •Participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer.
- •Use of other topical treatments on the skin in the treatment field. No other products are allowed except Aquaphor® ointment.
结局指标
主要结局
Improvement in patient reported outcome measures
时间窗: 3 weeks
Patient reported outcome survey results will be scored prior to and after compress treatment.
Compliance with compress application
时间窗: 3 weeks
Compliance will be measured as the proportion of subjects who complete 80% or more of the compresses. We will consider the study 'successful' if ≥ 80% of patients complete 80% or more of the compresses.
Occurrence of adverse events from compress application
时间窗: 3 weeks
The number of adverse events that occur in relation to the compress application will be tabulated during the course of the study.
次要结局
未报告次要终点
研究者
Amy Paller
Chair, Department of Dermatology
Northwestern University