Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-27 @ 10:19 AM
Study NCT ID:
NCT00892268
Status:
TERMINATED
Last Update Posted:
2010-04-27
First Post:
2009-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accural
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| UARIZ-07-0792-04 | None | None | View | |
| IRUSANAS0084 | None | None | View |