Exercise therapy to enhance heart health in post-menopausal women after breast cancer treatment

A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer

This study tests how different amounts of aerobic exercise can improve heart health in post-menopausal women who have finished treatment for early-stage breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 21 Years to 80 Years
• Sex: Female
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy, radiation
• Locations: 2 sites (Hartford, Connecticut and 1 other locations)
• Trial ID: NCT04458532 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of different amounts of aerobic exercise on cardiorespiratory fitness in post-menopausal women who have undergone treatment for early-stage breast cancer. Participants will engage in supervised aerobic training sessions, with their vital signs monitored to ensure safety. The research aims to determine how varying durations and intensities of exercise affect heart function, lung capacity, and overall cardiovascular health. The study will include assessments of how well participants' bodies utilize oxygen and how effectively their hearts pump blood.

Who should consider this trial

Good fit: Ideal candidates are post-menopausal women aged 21-80 who have completed treatment for early-stage breast cancer and exhibit exercise intolerance.

Not a fit: Patients who are not post-menopausal or those who have not completed definitive therapy for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve cardiovascular health and quality of life for post-menopausal women recovering from breast cancer.

How similar studies have performed: Other studies have shown positive outcomes with aerobic exercise interventions in cancer recovery, suggesting this approach is promising.

Eligibility criteria

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, 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:

* 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.

Where this trial is running

Hartford, Connecticut and 1 other locations

• Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only) — Hartford, Connecticut, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Jessica Scott, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jessica Scott, PhD

Conditions Early Stage Breast Cancer; Exercise Therapy; Aerobic Training; Post-Menopausal Women; 20-130