Exercise Preconditioning and Breast Cancer Cardiotoxicity
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 2/8/2019 |
| Start Date: | April 2016 |
| End Date: | December 2020 |
| Contact: | Gina M Ciavarella |
| Email: | Ciavarella.Gina@mayo.edu |
| Phone: | 480-342-6004 |
Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy
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.
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.
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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