Breast Cancer Clinical Trial

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Summary

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.

The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged 21-80 years
Female
MSK histologically confirmed early-stage operable breast cancer
Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
ECOG status of 0 or 1
Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week

If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.

a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.

Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.

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.
Willingness to be randomized to one of the study arms

Exclusion Criteria:

Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
Presence of metastatic disease
Any of the following 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
Respiratory failure
Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or
Room air desaturation at rest ≤ 85%
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

144

Study ID:

NCT01943695

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

144

Study ID:

NCT01943695

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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