Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
研究概览
简要总结
The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
- •Body Mass Index (BMI) 25-45 kg/m2
- •Has internet access
排除标准
- •History of 5 alpha reductase inhibitors prior 3 months
- •History of radiation therapy for cancer treatment
- •Taking active cancer treatment
- •Undergoing salvage therapy
- •Castration-resistant PCa
- •Evidence of metastasis
- •Evidence of biochemical recurrence
- •High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)
研究组 & 干预措施
Weight Loss and Weight Maintenance
Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.
干预措施: Weight Loss Program (Behavioral)
Weight Loss and Weight Maintenance
Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.
干预措施: Weight Maintenance Program (Behavioral)
Control
Participants will receive a standardized educational flyer about a healthy diet and exercise.
干预措施: Standardized educational flyer (Behavioral)
结局指标
主要结局
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
时间窗: Change from Baseline to Month 6
Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential.
次要结局
- Change in Weight(Change from Baseline to Month 6)
- Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors(Change from Baseline to Month 6)
- Change in Body Composition(Change from Baseline to Study End)
- Change in Quality of Life(Change from Baseline to Month 6)