Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Body weight
研究概览
简要总结
This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction [CER]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.
详细描述
PRIMARY OBJECTIVES:
I. Develop two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance (AS).
II. Determine the initial comparative effectiveness of two intervention programs (IF and CER) on weight loss and PCa progression outcomes.
SECONDARY OBJECTIVE:
I. Compare the effects of the interventions on biomarkers underlying obesity and PCa to provide mechanistic insights and potential surrogate biomarkers for PCa prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 years old or older (no upper limit)
- •Body mass index (BMI) >= 25 kg/m^2
- •English speaking
- •Not currently on weight loss medications
- •Prostate cancer patients who are under active surveillance (including observation) and actively followed at Roswell Park
- •Not under active treatment for other cancer diagnosis
- •Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- •Has not lost at least 10% of their body weight in the last 6 months
- •Has not had bariatric surgery in the last 10 years
- •Able to walk unassisted and continuously for 10 minutes
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Unable to consent
- •Unwilling or unable to follow protocol requirements
- •Unable to complete study measures in English
- •Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
- •Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
- •History of partial or radical prostatectomy
结局指标
主要结局
Change in Body weight
时间窗: Up to 6 months
Weight will be measured using a body composition monitor.
Changes in prostate cancer (PCa) progression
时间窗: Up to 6 months
Will assess changes in PCa progression indicated by serum prostate specific antigen (PSA) doubling time, and biopsy tumor upgrading and/or upstaging if required clinically, between the timepoints prior and post to the intervention. The timing of the intervention and data collection visits will be scheduled to correspond with the PCa patient's regular management check-up with their physician to allow their scheduled PSA test fall within at least a 6-month time window. For patients if prostate biopsy per clinical guidance is scheduled within 6 months after the intervention, the results from the biopsy post to the intervention as well as the nearest biopsy prior to the intervention will be requested. PSA test results (level and doubling time) and pathology reports on biopsies tissues (stage and grade) will be requested from the Biomedical Research Informatics Shared Resource for both baseline and follow-up visits and defined based on clinical criteria.
次要结局
- Change in Sexual functions(Up to 6 months)
- Change from baseline in Prostate Cancer related biomarkers(Up to 6 months)
- Change in Urinary functions(Up to 6 months)
- Physical activity(Up to 6 months)
- Dietary intake(Up to 6 months)
- Improvement of Quality of life(Up to 6 months)