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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT07199556
Eligibility Criteria:
Inclusion Criteria:
* Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).
* Surgical treatment completed and any surgery-related complications resolved.
* Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).
* Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.
* "Average pain" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.
* ECOG performance status of 0-2.
* Patients able to provide informed consent.
Exclusion Criteria:
* Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic/inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.
* Chemotherapy and/or radiotherapy completed within 28 days prior to enrollment or baseline visit, and/or unresolved Grade ≥2 side effects related to chemotherapy and/or radiotherapy, except for alopecia and peripheral neuropathy.
* Known allergy or hypersensitivity to Tenflex®.
* Pregnant or breastfeeding patients.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT07199556
Study Brief:
Protocol Section:
NCT07199556