ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00892268
Recruitment Status : Terminated (Poor accural)
First Posted : May 4, 2009
Last Update Posted : April 27, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Arizona

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Menopausal Symptoms Pain Procedure: acupuncture therapy Procedure: pain therapy Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
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
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Improvement in pain, as defined by the WOMAC global score at 6 weeks

Secondary Outcome Measures :
  1. Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
  2. Menopausal symptoms as defined by the FACT-ES


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892268


Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Leona B. Downey, MD University of Arizona

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 ( U.S. NIH Grant/Contract )
UARIZ-07-0792-04
IRUSANAS0084
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: May 2009

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:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms