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:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT04365569
Eligibility Criteria:
Inclusion Criteria:
* Breast cancer diagnosis (stage 0-III)
* Body mass index of 25mg/k2 or greater
* Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
* Able and willing to participate in nutrition counseling at Maroone Cancer Center
* Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
* Participants must have the ability to understand and the willingness to sign a written informed consent document
* Performance status 0 or 1 as per ECOG scale \[see Appendix IV\]
Exclusion Criteria:
* Body mass index below 25kg/m2
* No prior history of breast cancer
* History of metastatic disease
* Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
* Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04365569
Study Brief:
Protocol Section:
NCT04365569