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High-Intensity Interval Training for Stage I-III Breast Cancer Patients

2021年4月1日 更新者:University of Southern California

High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use

This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may cause side effects to the heart. Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab. Exercise may also help reduce fatigue and prevent cancer from coming back. High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery. This may also allow patients who cannot exercise for a long period of time to still be physically active. This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.

研究概览

详细说明

PRIMARY OBJECTIVES:

I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing high-intensity interval training (HIT).

II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.

III. To examine the effects of HIT on left ventricular function when compared to delayed group.

IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.

OUTLINE: Participants are randomized to 1 of 2 groups.

ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks.

ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I.

After completion of study, patients are followed up at weeks 9 and 17.

研究类型

介入性

注册 (实际的)

31

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

18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

女性

描述

Inclusion Criteria:

  • English or Spanish speaking
  • Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
  • Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
  • Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
  • Physician (oncologist) clearance to participate in exercise at moderate to high intensity
  • Have read and signed study informed consent document (ICF)
  • EXERCISE INCLUSION CRITERIA:
  • Normal body temperature (=< 100 degrees F)
  • Resting blood pressure and/or heart rate within normal limits
  • Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

Exclusion Criteria:

  • Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
  • Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
  • Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
  • Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
  • Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
  • EXERCISE EXCLUSION CRITERIA:
  • Presence of fever (>= 100 degrees F)
  • Resting blood pressure and/or heart rate outside normal limits
  • Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

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 (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
相关研究
辅助研究
其他名称:
  • 生活质量评估
辅助研究
Undergo HIT
有源比较器:Arm II (Delayed group)
Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT program as in Arm I.
相关研究
辅助研究
其他名称:
  • 生活质量评估
辅助研究

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
Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
大体时间:Up to 17 weeks
The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions. Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated. Feasibility will be assessed based on both program attendance as well as exercise time completed.
Up to 17 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
大体时间:Baseline to up to week 17
A mixed-effect regression model will be fit to compare the mean changes in VO2peak (ml/kg/min) between groups. The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on VO2peak (ml/kg/min) over time will also be examined.
Baseline to up to week 17
Change in left ventricular function
大体时间:Baseline to up to week 17
A mixed-effect model will be fit to compare the mean changes in left ventricular ejection fraction, left ventricular end-diastolic volume, left ventricular end-systolic volume, and peak filling time. The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on left ventricular function over time will also be examined.
Baseline to up to week 17

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:Christina Dieli-Conwright、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)

2015年9月29日

初级完成 (实际的)

2019年7月15日

研究完成 (实际的)

2019年7月15日

研究注册日期

首次提交

2015年5月21日

首先提交符合 QC 标准的

2015年5月21日

首次发布 (估计)

2015年5月27日

研究记录更新

最后更新发布 (实际的)

2021年4月5日

上次提交的符合 QC 标准的更新

2021年4月1日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1B-14-5 (其他标识符:USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (美国 NIH 拨款/合同)
  • NCI-2015-00579 (注册表标识符:CTRP (Clinical Trial Reporting Program))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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