Evaluating Race Specific AGE Accumulation As a Behavioral Biomarker That Can Reflect Optimal Health in Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.
研究概览
简要总结
The purpose of this study is to show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor response which may correlate with improved quality of life in PCa survivors. AGEs are produced by the body and are affected by lifestyle, weight and diet.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with non-metastatic Stage I-III Prostate Cancer
- •Age 45 years and older
- •Within 12 months of first histologic prostate cancer diagnosis.
- •Completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study.
- •ECOG Performance Status 0 or
- •Access to a telephone.
- •Able to read and understand written and spoken English.
- •Participants must be accessible for treatment and follow-up and must sign informed consent.
- •Subjects with known diabetes are permitted. However, they must be under active treatment for this condition.
- •Participants must past the cardiac rehabilitation center stress test.
排除标准
- •Planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study
- •Received chemotherapy or radiation therapy within 4 weeks of enrollment
- •Had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion).
- •Previously participated in Cardiac-Rehab
- •Have constrained mobility secondary to problems with balance, bone and/or joint disease
- •Have unstable angina or cardiovascular disease that prohibits exercise.
研究组 & 干预措施
Lifestyle Intervention
Patients assigned to the Physical Activity arm will undergo exercise testing protocol and have supervised physical activity interventions while on study. Patients will also complete questionnaires and have research blood drawn.
干预措施: Physical Activity (Behavioral)
Usual care
Patients will complete questionnaires and have research blood drawn.
结局指标
主要结局
Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.
时间窗: From baseline to up to 52 weeks
Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire.
时间窗: From baseline to up to 52 weeks
次要结局
- Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood(From baseline up to 52 weeks)