Topical Doxepin for Prevention and Management of Radiation-induced Dermatitis
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
研究概览
简要总结
Radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.
详细描述
The patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. All the patients will be treated by 3D conformal radiation therapy using CT -based treatment planning and multi leaf linear accelerators. The patients will be treated by conventional fractionation regimens to a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week). Every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to RTOG Acute Radiation Morbidity Scoring Criteria which scores from 0 to 4. The patients receive Doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. After acquiring written permission, the radiotherapy site will be photographed at the start and ending of the Doxepin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy
- •Participants must not be pregnant.
- •Participants treated with a total dose of 5000 cGy (25 fractions of 200 cGy, 5 days per week
排除标准
- •Patients who are not eligible
- •The presence of skin diseases in the radiation area
- •Patients have constipation, xerostomia, blurred vision, urinary retention
- •Hypersensitivity to doxepin
研究组 & 干预措施
doxepin cream
Patients use doxepin cream 5% twice daily for two weeks
干预措施: Doxepin cream 5% (Drug)
Placebo
Patients use cream without doxepin ingredient twice daily for two weeks
干预措施: Placebo (Other)
结局指标
主要结局
Grading of dermatitis was performed according to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria
时间窗: At the beginning of 5th week of radiotherapy to two weeks
at the beginning of 5th week of radiotherapy and use it for two weeks
次要结局
未报告次要终点
研究者
Golnaz Vaseghi
Isfahan University of Medical Sciences
Isfahan University of Medical Sciences