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Clinical Trials/NCT02842658
NCT02842658
Completed
N/A

Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy

Mayo Clinic1 site in 1 country1 target enrollmentApril 2016
ConditionsBreast Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Mayo Clinic
Enrollment
1
Locations
1
Primary Endpoint
Change in left ventricular ejection fraction
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in left ventricular ejection fraction

Time Frame: baseline, approximately 2 months

Echocardiography will be used to assess biventricular systolic function.

Change in diastolic function

Time Frame: baseline, approximately 2 months

Echocardiography will be used to assess biventricular diastolic function.

Study Sites (1)

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