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

NCT ID: NCT00892268

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Breast Cancer; Menopausal Symptoms; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture therapy

Intervention Type: PROCEDURE

Undergo acupuncture

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.

Group Type: ACTIVE_COMPARATOR

pain therapy

Intervention Type: PROCEDURE

Receive standard care

Interventions

acupuncture therapy

Undergo acupuncture

Intervention Type: PROCEDURE

pain therapy

Receive standard care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Arizona Cancer Center at University of Arizona Health Sciences Center

Principal Investigators

Leona B. Downey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Other Identifiers

P30CA023074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UARIZ-07-0792-04

Identifier Type: -

Identifier Source: secondary_id

IRUSANAS0084

Identifier Type: -

Identifier Source: secondary_id

CDR0000629150

Identifier Type: -

Identifier Source: org_study_id