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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01725633
Eligibility Criteria:
Inclusion Criteria:
* MSK histologically confirmed metastatic breast cancer
* Measurable disease (or nonmeasurable bone-only disease) assessed by CT or PET/CT performed as part of standard of care, at the discretion of the attending oncologist in the Breast Medicine Service
* ≥18 years of age;
* Life expectancy \>3 months;
* ECOG ≤ 1
* Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) . Participants who perform regular moderate or vigorous intensity exercise at least 5 days/week, for at least 30 minutes/session, are not eligible
* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
2. A respiratory exchange ratio ≥ 1.10;
3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
* Normal cardiac function (left ventricular ejection fraction ≥50%);
* Medical clearance from attending oncologist indicating no relative contraindications to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention;
* Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled
* Willing to be randomized to one of the study arms
* Female
Exclusion Criteria:
* Any of the following absolute contraindications to cardiopulmonary exercise testing:
1. Acute myocardial infarction within 3-5 days of any planned study procedures
2. Unstable angina
3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
4. Recurrent syncope
5. Active endocarditis;
6. Acute myocarditis or pericarditis
7. Symptomatic severe aortic stenosis
8. Uncontrolled heart failure
9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
10. Thrombosis of lower extremities
11. Suspected dissecting aneurysm
12. Uncontrolled asthma
13. Pulmonary edema
14. Room air desaturation at rest ≤ 85%
15. Respiratory failure
16. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
17. 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
* Presence of extensive skeletal metastases, defined as more than five (5) sites of bony disease, or any symptomatic site of disease in the spine, hip, or femur. Note that, patients with more than five bony sites may be deemed eligible at the discretion of the attending oncologist.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01725633
Study Brief:
Protocol Section:
NCT01725633