Status:
RECRUITING
Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Early Stage Breast Cancer
Eligibility:
FEMALE
21-80 years
Phase:
NA
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 ex...
Detailed Description
Prior to the initiation of every supervised aerobic training session, patient resting vital signs will be assessed to ensure the patient can safely proceed with the session. Vital signs, including res...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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
- 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.
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04458532
Start Date
October 8 2020
End Date
March 31 2027
Last Update
December 26 2025
Active Locations (2)
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1
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut, United States, 06102
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065