Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
NCT ID: NCT04458532
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2020-10-08
2027-03-31
Brief Summary
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The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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(A) breast cancer after completion of chemo
300 min/wk for 16 weeks, followed by 16 weeks of usual care.
Aerobic Training
300 min/wk for 16 weeks
(B) breast cancer after completion of chemo
150 min/wk for 32 weeks.
Aerobic Training
150 min/wk for 32 weeks
(C) breast cancer after completion of chemo
300 min/wk for 32 weeks.
Aerobic Training
300 min/wk for 32 weeks
(D) breast cancer after completion of chemo
150 min/wk for 16 weeks, followed by 16 weeks of usual care.
Aerobic Training
150 min/wk for 16 weeks
Interventions
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Aerobic Training
300 min/wk for 16 weeks
Aerobic Training
150 min/wk for 32 weeks
Aerobic Training
300 min/wk for 32 weeks
Aerobic Training
150 min/wk for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Female
* Surgically resected early stage (I-III) primary breast cancer
* Post-menopausal, defined as one of the following:
* Age ≥ 45 with no menses for at least 2 years
* Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist
* Estradiol level of ≤30 pg/mL
* An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:
* Surgery plus radiation
* Surgery plus chemotherapy
* Surgery plus trastuzumab
* Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)\].
Note: Normative values are available up to 80 years of age)
* Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, 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 comply with all study-related procedures.
Exclusion Criteria
* 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 (e.g., infection, renal failure, thyrotoxicosis)
* 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 distant metastatic disease (i.e., stage IV)
* 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.
21 Years
80 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jessica Scott, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Lee Jones, PhD
Role: CONTACT
Phone: 646-888-8103
Facility Contacts
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Andrew Salner, MD
Role: primary
Jessica Scott, PhD
Role: primary
Lee Jones, PhD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-130
Identifier Type: -
Identifier Source: org_study_id