Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- time to relapse
研究概览
简要总结
Green tea is extracted from steam treated leaves, allowing the preservation of catechins, the active elements of the infusion. Catechins are recognized for their anti-cancer activity. Catechins act on the capacity of cancer to disseminate to other organs because of their anti-protease action. Proteases are proteins capable of digesting the cancer environment and facilitating the progression of cancer cells to blood vessels which will bring them to distant organs. We know that ovarian cancer responds well to the initial treatment of chemotherapy but tends to recur rapidly. We intend to provide green tea with higher concentrations of catechins to women with complete remission of their ovarian cancer in an attempt to delay cancer relapse. We also intend to identify, with molecular technologies, the proteases involved in ovarian cancer recurrence and response to catechins. Our objective is to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to develop tools to predict which women will best benefit of the addition of green tea to their initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with ovarian serous carcinoma FIGO stage III or IV
- •patients showing complete response after oncological surgery and chemotherapy (paclitaxel-carboplatin, minimum 5 cycles, maximum 8 cycles), complete response being defined as 1) a negative complete physical examination 2) Serum CA-125 levels inferior to 35 U/mL 3) no evidence of diseased assessed by abdomino-perineal CT-scan
- •patients refraining from drinking tea other than provided by the study
- •patients who may absorb liquids orally
- •patients without any other malignancy (except for non-melanoma skin cancer)
- •patients not involved in an other study
- •patients who signed up informed consent form.
排除标准
- •exclusion criteria are implicit from inclusion criteria.
研究组 & 干预措施
1
干预措施: Double-Brewed Green Tea (Dietary Supplement)
结局指标
主要结局
time to relapse
时间窗: 36 months
次要结局
- toxicity(14th and 28th patients recruted and PRN)
研究者
Bernard Têtu
Professor, MD
CHU de Quebec-Universite Laval
