Exercise Preconditioning and Breast Cancer Cardiotoxicity (EXACCT)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A high-intensity interval exercise group
An Attention-Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Chemotherapy, Exercise
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
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
A high-intensity interval exercise group
An attention-control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in left ventricular ejection fraction
Echocardiography will be used to assess biventricular systolic function.
Change in diastolic function
Echocardiography will be used to assess biventricular diastolic function.
Secondary Outcome Measures
Full Information
NCT ID
NCT02842658
First Posted
April 15, 2016
Last Updated
February 20, 2020
Sponsor
Mayo Clinic
Collaborators
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT02842658
Brief Title
Exercise Preconditioning and Breast Cancer Cardiotoxicity
Acronym
EXACCT
Official Title
Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
Arizona State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Chemotherapy, Exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A high-intensity interval exercise group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
An attention-control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
A high-intensity interval exercise group
Intervention Description
To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
Intervention Type
Other
Intervention Name(s)
An Attention-Control Group
Intervention Description
Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
Primary Outcome Measure Information:
Title
Change in left ventricular ejection fraction
Description
Echocardiography will be used to assess biventricular systolic function.
Time Frame
baseline, approximately 2 months
Title
Change in diastolic function
Description
Echocardiography will be used to assess biventricular diastolic function.
Time Frame
baseline, approximately 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farouk Mookadam, MBBCh
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Exercise Preconditioning and Breast Cancer Cardiotoxicity
We'll reach out to this number within 24 hrs