Clinical trial NCT00892268: Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain
Official title: Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Menopausal Symptoms
Pain
Keywords: menopausal symptoms
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
breast cancer
pain
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-04
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Improvement in pain, as defined by the WOMAC global score at 6 weeks
Secondary outcomes:
measure: Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
measure: Menopausal symptoms as defined by the FACT-ES
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Leona B. Downey, MD
role: PRINCIPAL_INVESTIGATOR
References: