Aerobic Training in Metastatic Breast Cancer (Breast Mets)

April 4, 2023 updated by: Memorial Sloan Kettering Cancer Center

Phase II Trial of Aerobic Training in Metastatic Breast Cancer

This study is being done to examine the safety and feasibility of a supervised progressive exercise program in women diagnosed with metastatic breast cancer. Previous research among women with metastatic breast cancer has shown that some of the treatments commonly used in this population may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects in women with early-stage breast cancer receiving common cancer treatments. However, it is not known if supervised exercise training is a safe and feasible intervention in women with metastatic breast cancer. This study is designed to find out if supervised exercise training is safe as the patients undergo treatments for metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • MSK histologically confirmed metastatic breast cancer
  • Measurable disease (or nonmeasurable bone-only disease) assessed by CT or PET/CT performed as part of standard of care, at the discretion of the attending oncologist in the Breast Medicine Service
  • ≥18 years of age;
  • Life expectancy >3 months;
  • ECOG ≤ 1
  • Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) . Participants who perform regular moderate or vigorous intensity exercise at least 5 days/week, for at least 30 minutes/session, are not eligible

  • Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

    1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
    2. A respiratory exchange ratio ≥ 1.10;
    3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
    4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
  • Normal cardiac function (left ventricular ejection fraction ≥50%);
  • Medical clearance from attending oncologist indicating no relative contraindications to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention;
  • Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled
  • Willing to be randomized to one of the study arms
  • Female

Exclusion Criteria:

  • Any of the following absolute contraindications to cardiopulmonary exercise testing:

    1. Acute myocardial infarction within 3-5 days of any planned study procedures
    2. Unstable angina
    3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    4. Recurrent syncope
    5. Active endocarditis;
    6. Acute myocarditis or pericarditis
    7. Symptomatic severe aortic stenosis
    8. Uncontrolled heart failure
    9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
    10. Thrombosis of lower extremities
    11. Suspected dissecting aneurysm
    12. Uncontrolled asthma
    13. Pulmonary edema
    14. Room air desaturation at rest ≤ 85%
    15. Respiratory failure
    16. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
    17. Mental impairment leading to inability to cooperate.
  • Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
  • Presence of extensive skeletal metastases, defined as more than five (5) sites of bony disease, or any symptomatic site of disease in the spine, hip, or femur. Note that, patients with more than five bony sites may be deemed eligible at the discretion of the attending oncologist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Progressive Stretching Group
Behavioral: Progressive Stretching Group
Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).
Other: Blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
Experimental: Nonlinear Aerobic Training
Other: Blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
Behavioral: Nonlinear Aerobic Training
Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.
Other: Cardiopulmonary Exercise Testing (CPET)
At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of aerobic training
Time Frame: 2 years
Safety will be evaluated by the type and prevalence of adverse events during study-related assessments as well as aerobic training and progressive stretching sessions. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) will be used to grade toxicities during the trial.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of aerobic training
Time Frame: 2 years
feasibility will be evaluated by examining several different end points including rates of study eligibility and accrual, etc; however, sample size calculations are based on an integration of aerobic training attendance rate (in the aerobic training group) as well as global trial attrition rates. Together, these end points will be used to determine overall study feasibility.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSKCC 14-170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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