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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05716893
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years
* Female
* Diagnosed with primary breast cancer as defined by one of the following:
* Histological confirmation
* As per standard of care imaging
* Scheduled to receive neoadjuvant/adjuvant chemotherapy
* Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report
* Willingness to comply with all study-related procedures
* 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.
Exclusion Criteria:
* Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
* Receiving treatment for any other diagnosis of invasive cancer
* Distant metastatic malignancy of any kind
* Mental impairment leading to inability to cooperate
* Any of the following contraindications to cardiopulmonary exercise testing:
i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85%
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05716893
Study Brief:
Protocol Section:
NCT05716893