The Effects of Tahini Consumption on Radiotherapy Induced Dermatitis in Breast Cancer - A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- severity of dermatitis
研究概览
简要总结
This study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT).
50 eligible BC patients will randomly assign to consume tahini 48 gr per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with Brest Cancer undergoing adjutant Radiation therapy
排除标准
- •previous history of RT, MRM,
- •concomitant presence of two or more malignant tumors
- •metastasis to other areas
- •allergy or intolerance to tahini
- •skin diseases and wounds
- •severe liver and renal disease
- •autoimmune diseases
- •pregnant and lactating women
- •those who treated with hypo fraction RT
结局指标
主要结局
severity of dermatitis
时间窗: 4 weeks
Change from Baseline severity at 4 weeks. The radiation dermatitis will be assessed according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
professor
National Nutrition and Food Technology Institute