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Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients

Phase 2/Phase 3
45 Years
Not Enrolling
Breast Cancer

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Trial Information

Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients

This is aa randomized, controlled, pilot study to determine the safety and efficacy of
acupuncture as an adjunct to pharmacological treatment compared to pharmacological
intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors
in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be
enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC).
Patients in the treatment arm will receive acupuncture administered twice weekly for six
weeks and will be allowed to take pain medication as necessary. The control patients will
initially receive pain medication alone, then will cross-over to the acupuncture arm after
six weeks.

The primary endpoint of this study is to compare the change in joint pain related to
aromatase inhibitors in breast cancer patients treated with acupuncture and pharmacological
therapy compared to pharmacological intervention alone before and after treatment. The
primary efficacy endpoint will be a change in the Brief Pain Inventory-Short Form (BPI-SF)
before and after treatment. Secondary objectives of this study include a change in the
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, dosage of analgesics
(acetaminophen, NSAIDs or selective COX-2 inhibitors) consumed, quality of life as measured
by the Functional Assessment of Cancer Therapy-Breast (FACT-B), blood levels of IL and TNF,
frequency and severity of adverse events according to the National Cancer Institute (NCI)
Common Toxicity Criteria Version 3.0, and assessment of attitudes towards complementary and
alternative medicine.

The primary hypothesis is that acupuncture in conjunction with pharmacological treatment
will decrease joint pain related to the use of aromatase inhibitors in breast cancer
patients compared to pharmacological therapy alone. This hypothesis will be tested using
logistic regression with acupuncture (yes/no) as the predictor and the change in the BPI-SF
score after treatment (at six weeks) compared to baseline as the outcome. The logistic
model will allow for the adjustment of possible confounders such as age, body mass index and
years since menopause. Secondary outcomes include change in the WOMAC index, FACT-B
quality-of-life measure, dosage of analgesics consumed, and blood levels of IL-and TNF after
treatment compared to baseline. The change in all efficacy outcomes will be assessed in all
patients (including those who have delayed cross-over to acupuncture) before and after
acupuncture treatment. For the patients who receive immediate acupuncture treatment, all
efficacy outcomes will be reassessed at twelve weeks to examine the duration of effect upon
completion of acupuncture. All treatment-related adverse events will be reported for both
treatment arms. For the secondary endpoints, the differences between baseline, six weeks
and twelve weeks will be studied for each efficacy outcome measure using descriptive
statistics and graphical tools. Correlations between the biologic markers of inflammation
and the efficacy measures will be evaluated by tabular and graphical form.

The study will enroll a total of 40 patients, half of whom will be randomized to one of the
two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological
treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and
six weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale
of 0-10.

Inclusion Criteria


- Age>45 years

- Postmenopausal status defined as cessation of menses for >1 year or FSH>20 mIU/mL

- History of stage I or II, hormone receptor-positive breast cancer

- Currently taking a third-generation aromatase inhibitor (anastrazole, letrozole or

- Ongoing musculoskeletal pain in one or more joints (baseline BPI worst pain score > 3
points on a scale of 0 to 10)

- English-speaking

- Signed informed consent


- Previous treatment with acupuncture

- Inflammatory, metabolic or neuropathic arthropathies

- Bone fracture or surgery of the afflicted extremity during the past six months

- Current narcotic use, corticosteroid therapy or cortisone injections

- Severe concomitant illnesses or metastatic disease

- Severe coagulopathy or bleeding disorder

- Dermatological disease within the acupuncture area

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Reduction in joint pain as measured by BPI

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Dawn Hershman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • aromatase inhibitors
  • joint pain
  • symptoms control
  • Arthralgia
  • Breast Neoplasms



Columbia University New York, New York  10032-3784