Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01186367
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT01186367
Study Brief:
Protocol Section:
NCT01186367