Status:
TERMINATED
Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Menopausal Symptoms
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint ...
Detailed Description
OBJECTIVES: Primary * To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and aromatase i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00892268
Start Date
January 1 2008
End Date
October 1 2009
Last Update
April 27 2010
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