Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change of dermatitis grading
研究概览
简要总结
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer
详细描述
To compare the effect of each herb extracts to protect the skin from the adverse effects of radiation therapy in patients with breast cancer with herbal extract products.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years old or older,
- •Diagnosed with Breast cancer
- •On course of external Radiation therapy
排除标准
- •Previously underwent external Radiation therapy
- •Illiterate
结局指标
主要结局
Change of dermatitis grading
时间窗: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
RTOG (Radiation Therapy Oncology Group) Cooperative Group Common Toxicity Criteria Skin Grade 0:None or no change Grade 1:Scattered macular or papular eruption or erythema that is asymptomatic Grade 2:Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Grade 3:Generalized symptomatic macular, papular, or vesicular eruption Grade 4:Exfoliative dermatitis or ulcerating dermatitis Grade 5:If that toxicity caused the death of the patient.
次要结局
- Patient satisfaction with the cream(At 9 week from date of randomization)
研究者
Saengrawee Thanthong
Principal Investigator
Chulabhorn Cancer Center