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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023074 | U.S. NIH Grant/Contract | View source | |
| UARIZ-07-0792-04 | |||
| IRUSANAS0084 |
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Poor accural
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture therapy | Procedure | Undergo acupuncture |
| |
| pain therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pain, as defined by the WOMAC global score at 6 weeks |
| 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 |
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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
Hormone receptor-positive disease
PATIENT CHARACTERISTICS:
Post-menopausal status meeting the following criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Leona B. Downey, MD | University of Arizona | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D000760 | Anesthesia and Analgesia |
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| Procedure |
Receive standard care |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |