Exercise Preconditioning and Breast Cancer Cardiotoxicity

NCT ID: NCT02842658

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-10-18

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

A high-intensity interval exercise group

Intervention Type: OTHER

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.

Group Type: OTHER

An Attention-Control Group

Intervention Type: OTHER

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

Interventions

A high-intensity interval exercise group

To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farouk Mookadam, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

15-004656

Identifier Type: -

Identifier Source: org_study_id