NCT01597921终止不适用
Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
Water-Jel1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
详细描述
All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
- •Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
- •Patient able to understand the study designed and cooperate with instructions of use.
- •Patient able to sign informed consent
排除标准
- •Woman with lactose allergy (lactose intolerance are eligible)
- •Woman with known connective tissue disorder
- •Woman with uncontrolled diabetes
- •Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
- •Woman who is unable to sign an informed consent
研究者
Dr Merav Ben-David
Dr
Water-Jel
研究点 (1)
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