Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer

Last updated: July 8, 2026
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ductal Carcinoma In Situ (Dcis)

Treatment

Aerobic Training

Clinical Study ID

NCT04458532
20-130
  • Ages 21-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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, asdetermined 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 fullcompletion of definitive therapy for malignant disease. Definitive therapy isdefined as:

  • Surgery plus radiation

  • Surgery plus chemotherapy

  • Surgery plus trastuzumab

  • Exercise intolerance (i.e., patients must have a VO2peak below the predicted foractive age and sex-matched individuals. (+/- the technical error of 1.32mL/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 ECGfindings or other inappropriate response to exercise as determined by the PI, asdefined by any of the following criteria:

  • Achieving a plateau in oxygen consumption, concurrent with an increase in poweroutput;

  • A respiratory exchange ratio ≥ 1.10;

  • Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm ofage-predicted HRmax [HRmax = 220-Age[years]);

  • Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18on the BORG scale

  • Willingness to comply with all study-related procedures.

Exclusion

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 plannedstudy procedures

  • Thrombosis of lower extremities

  • Suspected dissecting aneurysm

  • Uncontrolled asthma

  • Pulmonary edema

  • Respiratory failure

  • Acute non-cardiopulmonary disorders that may affect exercise performance or beaggravated 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 thannon-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 theinvestigator, makes the participant a poor candidate for the trial.

Study Design

Total Participants: 152
Treatment Group(s): 1
Primary Treatment: Aerobic Training
Phase:
Study Start date:
October 08, 2020
Estimated Completion Date:
March 31, 2027

Study 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 resting heart rate and blood pressure, will be collected and monitored per ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc staff member observes any concerns that may compromise participant safety and/or the integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.

Connect with a study center

  • Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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