Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 6
- 主要终点
- Response to cancer treatment
研究概览
简要总结
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.
This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
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
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
- •Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
- •Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Allergies to any ingredients listed on the Xentigen Ingredient List
- •Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
- •Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
- •Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
- •Body Mass Index (BMI) <20kg/m2
- •Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months
- •Self-reported weight loss ≥ 10% in the last 6 months
研究组 & 干预措施
Fasting Mimicking Diet
Intermittent fasting using a fasting mimicking diet
干预措施: Fasting Mimicking Diet (FMD) (Behavioral)
Standard Anti-Cancer Diet
Standard Anti-Cancer Diet
干预措施: Standard Anti-Cancer Diet (Behavioral)
结局指标
主要结局
Response to cancer treatment
时间窗: 6 Month visit
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
次要结局
- Metabolic Toxicity 3(Change from Baseline to 6 Month visit)
- Self-reported energy levels(Change from Baseline to 6 Month visit)
- Castration resistance 1(6 Month visit)
- Castration resistance 2(6 Month visit)
- Metabolic Toxicity 1(Change from Baseline to 6 Month visit)
- Metabolic Toxicity 4(Change from Baseline to 6 Month visit)
- Self-reported overall well-being(Change from Baseline to 6 Month visit)
- Metabolic Toxicity 2(Change from Baseline to 6 Month visit)
研究者
Stephen Freedland
Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surger
Cedars-Sinai Medical Center