Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 68
- 主要终点
- Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation
研究概览
简要总结
The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ eighteen years
- •Eastern Cooperative Oncology Group performance status of 0-1
- •Normal hematologic, hepatic function and renal values
- •Forced expiratory volume 1 >800 cc
排除标准
- •The presence of rash or unhealed wound in the radiation field
- •A known allergy or hypersensitivity to EGCG
- •Pregnancy or lactation
- •History of/current connective tissue disorder
- •Prior radiation to the thorax
研究组 & 干预措施
EGCG group
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy.
干预措施: EGCG (Drug)
placebo
The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.
干预措施: placebo (Drug)
结局指标
主要结局
Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation
时间窗: Each patient will be enrolled for a 5-6 week trial
次要结局
- Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer(Each patient will be enrolled for a 5-6 week trial)
- Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation(Each patient will be enrolled for a 5-6 week trial)
研究者
Han Xi Zhao
Principal Investigator
Shandong Cancer Hospital and Institute