Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain
|ClinicalTrials.gov Identifier: NCT00892268|
Recruitment Status : Terminated (Poor accural)
First Posted : May 4, 2009
Last Update Posted : April 27, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Menopausal Symptoms Pain||Procedure: acupuncture therapy Procedure: pain therapy||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients|
|Study Start Date :||January 2008|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
Experimental: 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.
Procedure: acupuncture therapy
Active Comparator: 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.
Procedure: pain therapy
Receive standard care
- Improvement in pain, as defined by the WOMAC global score at 6 weeks
- Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
- Menopausal symptoms as defined by the FACT-ES
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892268
|Principal Investigator:||Leona B. Downey, MD||University of Arizona|