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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT00892268
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
* Must have moderate or worse arthralgia, as defined by a baseline WOMAC pain scale score ≥ 48
* Patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
* Hormone receptor-positive disease
PATIENT CHARACTERISTICS:
* Post-menopausal status meeting the following criteria:
* At least 12 months without spontaneous menstrual bleeding
* History of bilateral salpingo-oophorectomy with or without hysterectomy
* Age \> 55 with hysterectomy with or without oophorectomy
* Age \< 55 with hysterectomy without oophorectomy or with unknown status, and serum FSH in post-menopausal range within the past 4 weeks
* Not needle phobic
* Patients with a contraindication to NSAIDs (i.e., prior gastrointestinal bleed secondary to NSAIDs or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Concurrent chronic narcotics or NSAIDs allowed, but doses must be stable for ≥ the past month
* Concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
* At least 6 months since prior acupuncture
* No prior acupuncture for aromatase inhibitor-associated pain syndrome
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00892268
Study Brief:
Protocol Section:
NCT00892268