Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer

This is an interventional treatment trial for Early Stage Breast Cancer focused on measuring Exercise Therapy, Aerobic Training, Post-Menopausal Women, 20-130 Read More

Inclusion Criteria:

• Aged 21-80 years
• Female
• Surgically resected early stage (I-III) primary breast cancer

• Post-menopausal, defined as one of the following:

  • Age ≥ 45 with no menses for at least 2 years
  • Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist
  • Estradiol level of ≤30 pg/mL

• An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:

  • Surgery plus radiation
  • Surgery plus chemotherapy
  • Surgery plus trastuzumab
• Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals. Note: Normative values are available up to 80 years of age)

• 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 PI, 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
• Willingness to comply with all study-related procedures.

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 (e.g., 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 distant metastatic disease (i.e., stage IV)
• 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.