Exercise Preconditioning and Breast Cancer Cardiotoxicity
- Conditions
- Breast Cancer
- Registration Number
- NCT02842658
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction (pre-conditioning) and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.
- Detailed Description
The primary aim of this study is to determine the efficacy of a novel, high-intensity aerobic interval exercise preconditioning protocol to ameliorate anthracycline-mediated cardiac and skeletal muscle toxicity in women with breast cancer undergoing de novo chemotherapy.
Research Design:
Women with breast cancer scheduled to undergo de novo chemotherapy with anthracyclines will be enrolled. Qualified patients will be randomized to either 1) a high-intensity interval exercise group, or 2) an attention-control group.
Supervised exercise training will be carried out at the Mayo Clinic Cardiac rehabilitation center in Arizona on cycle ergometers using Electrocardiogram (EKG) telemetry. Patients in the high-intensity interval exercise group will perform four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR.
The attention-controls will receive counseling consistent with standard of care regarding physical activity during chemotherapy. Attention-control group will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.
Treatment for each group will commence 1-week prior to chemotherapy induction. The first dose of chemotherapy will be given within 16-18 hours of the last bout of exercise. High-intensity intermittent exercise (HIIE) training will be continued throughout four, 2-week cycles of chemotherapy (total training time = 9 weeks, 3 days/week).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
- Subjects will have been recently diagnosed with breast cancer (stage I, II or III)
- Subjects must be scheduled by their oncologist to undergo anthracycline based chemotherapy (doxorubicin and cyclophosphamide) in the neoadjuvant/adjuvant setting
- Unstable angina
- Myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- New York Heart Association class IV symptoms
- Complex ventricular arrhythmias
- Medical orthopedic conditions precluding stationary cycling
- Medical conditions precluding neuropsychological assessment
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Untreated high-risk proliferative retinopathy
- Recent retinal hemorrhage
- Uncontrolled hypertension
- Sodium and/or Potassium ≥ Grade 2
- Pregnant Women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in left ventricular ejection fraction baseline, approximately 2 months Echocardiography will be used to assess biventricular systolic function.
Change in diastolic function baseline, approximately 2 months Echocardiography will be used to assess biventricular diastolic function.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Arizona🇺🇸Scottsdale, Arizona, United States