Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in body composition
研究概览
简要总结
This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.
详细描述
PRIMARY OBJECTIVES:
I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.
II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Biopsy-confirmed prostate adenocarcinoma of any stage/grade
- •Prescribed or already receiving continuous ADT for < 5 years
- •Hemoglobin > 11 g/dL
- •Creatinine < 1.5 x upper limit of normal (ULN), AST or ALT <2 x ULN within 6 months prior to enrollment
- •Liver function tests < 2 x ULN
- •Able to walk unassisted at least 100 meters (200 steps) or ECOG <= 1
- •No contraindications to any aspect of participation, including aerobic exercise
- •Participant must be able to read, write, and understand the English language and be able to provide written consent
- •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
- •Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
- •Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
- •Overall medical frailty (clinician discretion)
- •Any condition contraindicating additional blood collection beyond standard of care
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
研究组 & 干预措施
Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
干预措施: Exercise Intervention (Behavioral)
Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
干预措施: Dietary Intervention (Dietary Supplement)
Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
干预措施: Educational Intervention (Other)
Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
干预措施: Survey Administration (Other)
结局指标
主要结局
Changes in body composition
时间窗: Baseline up to 6 months
Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.
次要结局
- cytokines concentration(Baseline up to 6 months)
- Changes in functional capacity muscle strength(Baseline up to 6 months)
- Changes in physical activity(Baseline up to 6 months)
- Changes in muscle strength(Baseline up to 6 months)
- Change in body composition(Baseline up to 6 months)
- myokines concentration(Baseline up to 6 months)
- Changes in dietary intake(Baseline up to 6 months)
- Change in Respiratory Muscle Strength(Baseline up to 6 months)
- Health related quality of life Short Form(Up to 6 months)
- Change in fatigue(Baseline up to 6 months)