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

This study has been terminated.
(Poor accural)
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00892268
First received: May 1, 2009
Last updated: April 23, 2010
Last verified: May 2009
  Purpose

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 Intervention Phase
Breast Cancer
Menopausal Symptoms
Pain
Procedure: acupuncture therapy
Procedure: pain therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Improvement in pain, as defined by the WOMAC global score at 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels [ Designated as safety issue: No ]
  • Menopausal symptoms as defined by the FACT-ES [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Undergo acupuncture
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892268

Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Leona B. Downey, MD University of Arizona
  More Information

No publications provided

Responsible Party: Leona B. Downey, Arizona Cancer Center at University of Arizona Health Sciences Center
ClinicalTrials.gov Identifier: NCT00892268     History of Changes
Other Study ID Numbers: CDR0000629150, P30CA023074, UARIZ-07-0792-04, IRUSANAS0084
Study First Received: May 1, 2009
Last Updated: April 23, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
menopausal symptoms
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
breast cancer
pain

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014