NCT03546803已完成不适用
Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- compare radiation dermatitis severity
研究概览
简要总结
This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18years.
- •Patient has initial or recurrent disease
- •Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
- •Willing to consent for photography of radiation field
- •Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days).
- •At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician
- •Biologic effective dose of >42 Gy10 as calculated using the web site EQD2.com.
排除标准
- •Unable to provide informed consent
- •Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult
- •Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates
- •Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study
- •Subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
- •The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
结局指标
主要结局
compare radiation dermatitis severity
时间窗: 3 months (+/- 1 month) following the completion of radiation therapy
To compare radiation dermatitis severity in irradiated skin protected by a liquid skin protectant (3M™ Cavilon™ Advanced Skin Protectant) that rapidly dries versus uncovered skin (internal control) as determined by a panel.
次要结局
未报告次要终点
研究者
Ivy A. Petersen, M.D.
Radiation Oncology Consultant
Mayo Clinic
研究点 (1)
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