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

NCT00892268 | Terminated Phase 2 DMC

• 4 other identifiers: CDR0000629150P30CA023074UARIZ-07-0792-04IRUSANAS0084
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Menopausal Symptoms; Pain

Keywords

menopausal symptoms; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; breast cancer; pain

Outcome Measures

Primary Outcomes (1)

• Improvement in pain, as defined by the WOMAC global score at 6 weeks

Secondary Outcomes (2)

• Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels

• Menopausal symptoms as defined by the FACT-ES

Study Arms (2)

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.

Procedure: acupuncture therapy

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.

Procedure: pain therapy

Interventions

acupuncture therapy PROCEDURE

Undergo acupuncture

Arm I

pain therapy PROCEDURE

Receive standard care

Arm II

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Acupuncture Therapy; Analgesia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Anesthesia and Analgesia

Study Officials

• Leona B. Downey, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 27, 2010

Record last verified: 2009-05