Breast Cancer Clinical Trial

Aerobic Training in Metastatic Breast Cancer

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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:

Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
A respiratory exchange ratio ≥ 1.10;
Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
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:

Acute myocardial infarction within 3-5 days of any planned study procedures
Unstable angina
Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
Recurrent syncope
Active endocarditis;
Acute myocarditis or pericarditis
Symptomatic severe aortic stenosis
Uncontrolled heart failure
Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
Thrombosis of lower extremities
Suspected dissecting aneurysm
Uncontrolled asthma
Pulmonary edema
Room air desaturation at rest ≤ 85%
Respiratory failure
Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
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 is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT01725633

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 2 Locations for this study

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

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Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT01725633

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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