Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer
1 other identifier
interventional
152
1 country
2
Brief Summary
This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 25, 2026
March 1, 2026
6.5 years
July 2, 2020
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate
A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change \<1.32 ml O2.kg-1.min-1 will be considered a non-response.
32 weeks
Study Arms (4)
(A) breast cancer after completion of chemo
EXPERIMENTAL300 min/wk for 16 weeks, followed by 16 weeks of usual care.
(B) breast cancer after completion of chemo
EXPERIMENTAL150 min/wk for 32 weeks.
(C) breast cancer after completion of chemo
EXPERIMENTAL300 min/wk for 32 weeks.
(D) breast cancer after completion of chemo
ACTIVE COMPARATOR150 min/wk for 16 weeks, followed by 16 weeks of usual care.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 21-80 years
- 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;
- +4 more criteria
You may not qualify if:
- 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
- Respiratory failure
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2020
First Posted
July 7, 2020
Study Start
October 8, 2020
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.