Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 45-80 years
- •Has been diagnosed with early-stage breast cancer
- •Post-menopausal, defined as :
- •Age ≥ 45 with no menses for at least 2 years
- •Chemically induced menopause through ovarian suppression, as determined by the primary oncologist
- •An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as:
- •Surgery plus radiation
- •Surgery plus chemotherapy
- •Surgery plus trastuzumab
- •Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment.
Exclusion Criteria
- •Any of the following absolute contraindications to cardiopulmonary exercise testing:
- •Acute myocardial infarction within 3-5 days of any planned study procedures;
- •Unstable angina;
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
- •Recurrent syncope;
- •Active endocarditis;
- •Acute myocarditis or pericarditis;
- •Symptomatic severe aortic stenosis;
- •Uncontrolled heart failure;
- •Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
Outcomes
Primary Outcomes
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
Time Frame: 16 weeks
VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).