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Trial record 1 of 1 for:    NCT02842658
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Exercise Preconditioning and Breast Cancer Cardiotoxicity (EXACCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842658
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: A high-intensity interval exercise group Other: An Attention-Control Group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Change in left ventricular ejection fraction [ Time Frame: baseline, approximately 2 months ]
    Echocardiography will be used to assess biventricular systolic function.

  2. Change in diastolic function [ Time Frame: baseline, approximately 2 months ]
    Echocardiography will be used to assess biventricular diastolic function.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Arizona State University
Investigators
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Principal Investigator: Farouk Mookadam, MBBCh Mayo Clinic
Additional Information:
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02842658    
Other Study ID Numbers: 15-004656
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mayo Clinic:
Chemotherapy
Exercise
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases