Clinical trial NCT02842658: Exercise Preconditioning and Breast Cancer Cardiotoxicity
Official title: Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Chemotherapy
Exercise
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2016-07-25
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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
* Untreated high-risk proliferative retinopathy
* Recent retinal hemorrhage
* Uncontrolled hypertension
* Sodium and/or Potassium ≥ Grade 2
* Pregnant Women

Primary outcomes:
measure: Change in left ventricular ejection fraction
timeFrame: baseline, approximately 2 months
measure: Change in diastolic function
timeFrame: baseline, approximately 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Farouk Mookadam, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: