A Phase III Randomized, Multicenter, Two Arms Double-blind Trial Versus Placebo, Evaluating the Interest of a Dietary Supplementation With Docosahexaenoic Acid (DHA) During Chemotherapy for Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 22
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).
详细描述
Local relapses and metastases make breast cancer a deadly disease. A major goal remains the improvement of treatment efficacy, meaning increasing toxicity to tumor tissue, without additional toxicity to non-tumor tissues.
The literature indicates that DHA sensitizes breast malignant tumors, but not non-tumor tissues, to chemotherapy and to radiotherapy through a variety of mechanisms. DHA enrichment of tissues can be achieved through a dietary supplementation of DHA-containing oils, such as fish oil, both in experimental animal models or in humans. Therefore, this represents an original nutritional approach to increase the activity of anticancer treatments through an enhanced specificity toward tumor tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic breast cancer requiring first-line taxanes or anthracyclines based chemotherapy
- •HER2 negative, HR positive
- •Life expectancy > 3 months
- •ECOG Performance Status < or = 2 within 15 days before randomization
- •Measurable and/or evaluable disease according to RECIST criteria 1.1
- •Age > or = 18 years and < or = 80 years
- •Body Mass Index (BMI)>17 for patients < 70 years and BMI>21 for patients > 70 years, within 15 days before randomization
- •Hepatic parameters : total bilirubin strictly normal, AST and ALT < or = 3xULN (5 if liver metastases) within 15 days before randomization
- •Signed written informed consent
排除标准
- •Triple negative breast cancer or HER2 over expression
- •Symptomatic central nervous system metastases
- •Previous chemotherapy for metastatic breast cancer
- •Obesity with BMI > 35 within 15 days before randomization
- •Presence of another invasive cancer
- •Uncontrolled Cardiac disease or uncontrolled hypertension
- •Milk protein intolerance
- •Known food allergy to fish
- •Women of childbearing potential not using adequate contraceptive measures, pregnant or breast feeding.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 4 months
PFS is defined as time from randomization to disease progression or death.
次要结局
- DHA plasma level(Before dietary supplementation (at C1), and after 4 months of dietary supplementation.)
- Objective Response Rate (ORR)(The objective response is the best objective response observed from the start of treatment to progression.)
- Time To Progression (TTP)(First progression)
- Pain evaluation(4 months)
- Neuropathy evaluation(4 months)
- Safety ans tolerance of dietary supplementation/chemotherapy association(4 months)
- Quality Of Life (QOL)(At C1, after 4 months of chemotherapy, and at the end of chemotherapy.)
- Overall Survival (OS)(3 years after last chemotherapy in study)
- Dietary supplementation compliance(4 months)