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

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