Exercise Preconditioning and Breast Cancer Cardiotoxicity (EXACCT)
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|ClinicalTrials.gov Identifier: NCT02842658|
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : February 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: A high-intensity interval exercise group Other: An Attention-Control Group||Not Applicable|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||October 18, 2019|
|Actual Study Completion Date :||October 18, 2019|
Active Comparator: A high-intensity interval exercise group
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.
Other: A high-intensity interval exercise group
To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
An attention-control group
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.
Other: An Attention-Control Group
Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842658
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Farouk Mookadam, MBBCh||Mayo Clinic|