Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Completion Rate of Use of KeraStat Cream
研究概览
简要总结
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck.
Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.
详细描述
Primary Objective(s)
• To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer.
Secondary Objective(s)
- To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care.
- To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating:
- Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis,
- Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and
- Dermatologic-specific quality of life assessment
- To estimate the amount of KeraStat Cream used per patient and coverage on the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy
- •Able and willing to sign protocol consent form
- •Able and willing to complete tolerability and quality of life assessments
- •Able and willing to have photographs of the affected area taken regularly
排除标准
- •Women who are pregnant, lactating/nursing or plan to become pregnant
- •Previous radiation therapy to the area to be treated with radiation therapy
- •Active, medically necessary use of topical corticosteroids in the irradiation area
- •Active scleroderma or lupus requiring systemic medication
- •Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)
结局指标
主要结局
Completion Rate of Use of KeraStat Cream
时间窗: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.
次要结局
- Number of Participants With Grade 2+ Radiation Dermatitis(Up to 1 month post treatment with radiation therapy (6-7 weeks))
- Number of Participants Discontinuing Skin Care Regimen(Up to 1 month post treatment with radiation therapy (6-7 weeks))
- Number of Participants Reporting Radiation Skin Reaction(Up to 1 month post treatment with radiation therapy)
- Dermatology Life Quality Index Questionnaire(At weeks 1-6 and up to 1 month post treatment with radiation therapy)
- Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage(Up to 1 month post treatment with radiation therapy (7 weeks))