Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Linear Aerobic Training
* Behavioral: Nonlinear Aerobic Training
* Behavioral: Progressive Stretching
* Other: Cardiopulmonary exercise test (CPET)
* Other: Blood draws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 45-80 years Female 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. Weight of < 205 kgs ECOG status of 0 or 1 Life expectancy ≥ 6 months Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week. Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H. Willing to be randomized to one of the study arms Able to complete an acceptable baseline CPET, in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: Achieving a plateau in oxygen consumption, concurrent with an increase in power output; A respiratory exchange ratio ≥ 1.10; Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]); Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. 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 Thrombosis of lower extremities; Suspected dissecting aneurysm; Uncontrolled asthma; Pulmonary edema; Respiratory failure; Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); Presence of any other concurrent, actively treated malignancy History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) Presence of metastatic disease Room air desaturation at rest ≤ 85% Mental impairment leading to inability to cooperate Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linear Aerobic Training<br>The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline. | Behavioral: Linear Aerobic Training<br>* The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).<br>Other: Cardiopulmonary exercise test (CPET)<br> <br> Other: Blood draws<br>* Complete blood count<br>|
| Experimental: Nonlinear Aerobic Training<br>The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and and as well as the CPET performed at Week 8. | Behavioral: Nonlinear Aerobic Training<br>* The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).<br>Other: Cardiopulmonary exercise test (CPET)<br> <br> Other: Blood draws<br>* Complete blood count<br>|
| Experimental: Progressive Stretching Group (Attention control)<br>The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes). | Behavioral: Progressive Stretching<br>* All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.<br>Other: Cardiopulmonary exercise test (CPET)<br> <br> Other: Blood draws<br>* Complete blood count<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption. | VO2 or peak oxygen consumption will be measured at 3 time-points. Baseline, mid-point (8 weeks), and post-intervention (16 weeks). | 3 time-points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, Linear Versus Nonlinear Aerobic Training, 15-147