Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Completion of the resistance training program with at least 80% of the sessions attended
研究概览
简要总结
This randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To examine the effects of progressive, structured resistance training (RT) program , with and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence additional outcomes such as physical function, quality of life (QOL) and molecular pathways that regulate skeletal muscle.
SECONDARY OBJECTIVES:
I. To examine the effects of a structured RT program, with and without PS, on muscle strength, physical function, and QOL in PCS on ADT .
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosed with prostate cancer
- •Treatment with androgen deprivation therapy (ADT) (gonadotropin-releasing hormone [GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer
- •Receiving ADT for a minimum of 12 weeks before enrollment into the study
- •Planned ADT for the duration of the 12-week study period
- •Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies
- •No opioid-requiring cancer related pain
- •Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living
- •Permission from treating/study physician to participate in RT
排除标准
- •No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry)
- •History of allergic reactions to whey protein
- •Milk protein intolerance/allergies (lactose intolerance is acceptable)
- •Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
- •Recovered from major surgery within the last 6 months
- •Acute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina)
- •Stroke within the past 2 years
- •Neurologic and/or orthopedic limitations that preclude the participation in the training program (e.g. bone metastases that may pose a high risk of pathologic fracture)
- •Subjects currently participating in a RT program
研究组 & 干预措施
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: exercise intervention (Behavioral)
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: nutritional supplementation (Dietary Supplement)
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: quality-of-life assessment (Procedure)
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: questionnaire administration (Other)
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: pharmacological study (Other)
Arm I (RT + PS)
Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
干预措施: exercise intervention (Behavioral)
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
干预措施: quality-of-life assessment (Procedure)
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
干预措施: questionnaire administration (Other)
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
干预措施: pharmacological study (Other)
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
干预措施: laboratory biomarker analysis (Other)
Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.
干预措施: nutritional supplementation (Dietary Supplement)
Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.
干预措施: quality-of-life assessment (Procedure)
Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.
干预措施: questionnaire administration (Other)
Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.
干预措施: pharmacological study (Other)
Arm III (protein supplementation)
Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I.
干预措施: laboratory biomarker analysis (Other)
Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
干预措施: quality-of-life assessment (Procedure)
Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
干预措施: questionnaire administration (Other)
Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
干预措施: pharmacological study (Other)
Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Completion of the resistance training program with at least 80% of the sessions attended
时间窗: 12 weeks
Compliance with protein supplementation
时间窗: 12 weeks
Change in lean body mass
时间窗: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Change in strength
时间窗: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
Change in quality of life
时间窗: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
次要结局
未报告次要终点