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| Name | Class |
|---|---|
| Arizona State University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A high-intensity interval exercise group | Active Comparator | Supervised exercise training with be carried out at the Mayo Clinic Cardiac rehabilitation center on cycle ergometers using EKG telemetry. Treatment will begin one week prior to chemotherapy and is tailored around 8 weeks. |
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| An attention-control group | Other | Patients will receive counseling regarding physical activity during chemotherapy. Patients will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A high-intensity interval exercise group | Other | To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction | Echocardiography will be used to assess biventricular systolic function. | baseline, approximately 2 months |
| Change in diastolic function | Echocardiography will be used to assess biventricular diastolic function. | baseline, approximately 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farouk Mookadam, MBBCh | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| An Attention-Control Group | Other | Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |