Acupuncture for Aromatase Inhibitor Induced Joint Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Cancer

In brief

This is a 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 (AI) 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 investigators hypothesize that acupuncture will reduce AI induced joint symptoms. 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.

Key facts

Study ID

NCT00826397

Run by

Columbia University

People needed

40

Starts

2005-06-01

Expected to finish

2009-09-01

Last updated by the study team

2017-11-06

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age>45 years
• Postmenopausal status defined as cessation of menses for >1 year or follicle- stimulating hormone (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 exemestane)
• 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

You may not qualify if…

• 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

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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