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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT03953157
Eligibility Criteria:
Inclusion Criteria:
* At least 6 months since breast cancer diagnosis up to 2 years since diagnosis.
* Diagnosed with localized breast cancer, up to stage IIIa.
* Has been taking aromatase inhibitor (AIs) for at least six months.
* Has been experiencing mild to moderate arthralgia (joint pain) for at least 2 months determined by the Brief Pain Inventory (BPI).
* At least 6 months post chemotherapy or radiation treatment.
* Subjects must be in good health as determined by medical history, physical examination, iDXA scan and clinical laboratory measurements.
* Postmenopausal either natural or surgical or postmenopausal caused by ovarian suppression treatments administered to premenopausal women.
* Currently taking aromatase inhibitor medication.
Exclusion Criteria:
* Diagnosed with metastatic breast cancer.
* Currently undergoing chemotherapy or radiation treatment.
* Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
* A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
* Taking bisphosphonates or any other medication for bone loss.
* Significant cardiac, pulmonary, renal, liver or psychiatric disease.
* Currently undergoing or engaging in a regular exercise program.
* Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise.
* Body mass index (BMI) greater than 40 kg/m\^2.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT03953157
Study Brief:
Protocol Section:
NCT03953157