Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain

Study Overview
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Brief Summary
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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 pain caused by aromatase inhibitors. PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works compared with medication in reducing pain in postmenopausal women with breast cancer and joint pain.

Detailed Description
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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 inhibitor (AI)-associated arthralgia. Secondary To identify biologic correlates to acupuncture efficacy in this specific syndrome of AI-associated pain. To evaluate the efficacy of acupuncture in these patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms: Arm I: Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks. Arm II: Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I. Patients are assessed periodically for improvement in pain, menopausal symptoms, and overall quality of life by the WOMAC, Brief Pain Inventory, and FACT-ES questionnaires. Blood samples are collected at baseline, 6 weeks, 3 months, and 6 months for biomarker studies of brain-derived neurotrophic factor and serotonin-transporter gene polymorphisms levels by ELISA. After completion of study therapy, patients are followed at 1 week, 6 weeks, 3 months, and 6 months.

Official Title
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Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients

Conditions
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Breast Cancer, Menopausal Symptoms, Pain

Intervention / Treatment
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* Procedure: acupuncture therapy
* Procedure: pain therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks. | Procedure: acupuncture therapy<br>* Undergo acupuncture<br>|
| Active Comparator: Arm II<br>Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I. | Procedure: pain therapy<br>* Receive standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain, as defined by the WOMAC global score at 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels |  |  | 
| Menopausal symptoms as defined by the FACT-ES |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopausal symptoms, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, breast cancer, pain