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Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients

Phase 2
Not Enrolling
Breast Cancer, Menopausal Symptoms, Pain

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Trial Information

Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients



- 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.


- 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

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Safety Issue:


Principal Investigator

Leona B. Downey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona


United States: Federal Government

Study ID:




Start Date:

January 2008

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • Menopausal Symptoms
  • Pain
  • menopausal symptoms
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • breast cancer
  • pain
  • Arthralgia
  • Breast Neoplasms