Exercise Preconditioning and Breast Cancer Cardiotoxicity

Breast Cancer Clinical Trial

— EXACCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842658
• Other study ID #: 15-004656
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 18, 2019

Study information

• Verified date: February 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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 be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction	Echocardiography will be used to assess biventricular systolic function.	baseline, approximately 2 months
Primary	Change in diastolic function	Echocardiography will be used to assess biventricular diastolic function.	baseline, approximately 2 months

External Links

•   Mayo Clinic Clinical Trials