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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT03498157
Eligibility Criteria:
Inclusion Criteria:
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
* Not metastatic (stage \<4)
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Scheduled for lump- or mastectomy at Penn State Cancer Institute
* ≥ 2 weeks till primary treatment
* Primary attending surgeon approval
Exclusion Criteria:
* Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
* Not fluent in written and spoken English
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
* Pregnant women
* Engaging in systematic intense exercise training (at least 1h twice per week)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03498157
Study Brief:
Protocol Section:
NCT03498157