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Resistance Training and Protein Supplementation for Prostate Cancer Survivors

2019年6月17日 更新者:University of Southern California

Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

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.

研究概览

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

介入性

注册 (实际的)

43

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90033
        • USC Norris Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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:
  • 生活质量评估
相关研究
其他名称:
  • 药理学研究
Receive whole body RT
Given whey protein supplementation PO
实验性的:Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
相关研究
辅助研究
辅助研究
其他名称:
  • 生活质量评估
相关研究
其他名称:
  • 药理学研究
Receive whole body RT
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.
相关研究
辅助研究
辅助研究
其他名称:
  • 生活质量评估
相关研究
其他名称:
  • 药理学研究
Given whey protein supplementation PO
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.
相关研究
辅助研究
辅助研究
其他名称:
  • 生活质量评估
相关研究
其他名称:
  • 药理学研究

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
Completion of the resistance training program with at least 80% of the sessions attended
大体时间:12 weeks
12 weeks
Compliance with protein supplementation
大体时间:12 weeks
12 weeks
Change in lean body mass
大体时间:Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Baseline up to 12 weeks
Change in strength
大体时间:Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
Baseline up to 12 weeks
Change in quality of life
大体时间:Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
Baseline up to 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年7月8日

初级完成 (实际的)

2017年3月10日

研究完成 (实际的)

2018年8月7日

研究注册日期

首次提交

2013年7月24日

首先提交符合 QC 标准的

2013年7月24日

首次发布 (估计)

2013年7月26日

研究记录更新

最后更新发布 (实际的)

2019年6月19日

上次提交的符合 QC 标准的更新

2019年6月17日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 4P-13-2
  • P30CA014089 (美国 NIH 拨款/合同)
  • NCI-2013-01360 (注册表标识符:CTRP (Clinical Trial Reporting Program))
  • HS-13-00315

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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