A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Drop-out rate
研究概览
简要总结
This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for participation in this trial, the subject must:
- •Be willing and able to provide written informed consent for the trial.
- •Be male at birth and least 18 years of age on day of signing informed consent.
- •Have measurable prostate cancer disease and be eligible for androgen deprivation therapy.
- •Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation).
- •Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
- •Subjects must have a life expectancy of at least 6 months.
排除标准
- •Has an ECOG performance of 2 or higher.
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment.
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
- •Has any other medical intervention or condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.
- •Is not willing and able to provide written informed consent for the trial.
研究组 & 干预措施
Intermittent Fasting
Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study.
干预措施: Intermittent Fasting (Other)
结局指标
主要结局
Drop-out rate
时间窗: 3 years
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Enrollment rate
时间窗: 3 years
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
次要结局
- Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.(3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.(3 years)
研究者
Roberto Pili
Associate Dean for Cancer Research and Integrative Oncology
State University of New York at Buffalo