Exercise Preconditioning and Breast Cancer Cardiotoxicity (EXACCT)

February 20, 2020 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in left ventricular ejection fraction
Time Frame: baseline, approximately 2 months
Echocardiography will be used to assess biventricular systolic function.
baseline, approximately 2 months
Change in diastolic function
Time Frame: baseline, approximately 2 months
Echocardiography will be used to assess biventricular diastolic function.
baseline, approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Arizona State University

Investigators

  • Principal Investigator: Farouk Mookadam, MBBCh, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 18, 2019

Study Completion (Actual)

October 18, 2019

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-004656

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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