Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
研究概览
地位
条件
详细说明
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:
I. To examine the effects of a progressive, structured RT program, with and without PS, on anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.
II. To examine the effects of a progressive, structured RT program, with and without PS, on bone turnover markers and bone mineral density in PCS on ADT.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: 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.
ARM II: Patients undergo total body RT and stretching as in Arm I.
ARM III: 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, may undergo the RT program as in Arm 1.
ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient may undergo total body RT as in Arm 1.
After completion of study treatment, patients are followed up periodically.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90033
- USC Norris Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.
|
相关研究
辅助研究
辅助研究
其他名称:
相关研究
其他名称:
Receive whole body RT
Given whey protein supplementation PO
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实验性的:Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
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相关研究
辅助研究
辅助研究
其他名称:
相关研究
其他名称:
Receive whole body RT
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实验性的: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.
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相关研究
辅助研究
辅助研究
其他名称:
相关研究
其他名称:
Given whey protein supplementation PO
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有源比较器: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.
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相关研究
辅助研究
辅助研究
其他名称:
相关研究
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Completion of the resistance training program with at least 80% of the sessions attended
大体时间:12 weeks
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12 weeks
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Compliance with protein supplementation
大体时间:12 weeks
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12 weeks
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Change in lean body mass
大体时间:Baseline up to 12 weeks
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Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
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Baseline up to 12 weeks
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Change in strength
大体时间:Baseline up to 12 weeks
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Intent-to-treat models will be computed using repeated measures ANOVA.
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Baseline up to 12 weeks
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Change in quality of life
大体时间:Baseline up to 12 weeks
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Intent-to-treat models will be computed using repeated measures ANOVA.
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Baseline up to 12 weeks
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合作者和调查者
调查人员
- 首席研究员:E. Todd Schroeder、University of Southern California
出版物和有用的链接
一般刊物
- Dawson JK, Dorff TB, Tuzon C, Rice JC, Schroeder ET, Lane CJ, Gross ME, Dieli-Conwright CM. Effect of Periodized Resistance Training on Skeletal Muscle During Androgen Deprivation Therapy for Prostate Cancer: A Pilot Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211035442. doi: 10.1177/15347354211035442.
- Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
- Kiwata JL, Dorff TB, Todd Schroeder E, Salem GJ, Lane CJ, Rice JC, Gross ME, Dieli-Conwright CM. A pilot randomised controlled trial of a periodised resistance training and protein supplementation intervention in prostate cancer survivors on androgen deprivation therapy. BMJ Open. 2017 Jul 10;7(7):e016910. doi: 10.1136/bmjopen-2017-016910.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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