Acupuncture for Aromatase Inhibitor Induced Joint Pain

Phase

N/A

Condition

Cancer

Breast Cancer

Muscle Pain

Treatment

N/A

Clinical Study ID

NCT00826397

AAAB2299

Ages > 45
Female

Study Summary

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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

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

Exclusion

EXCLUSION CRITERIA:

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

Study Design

June 01, 2005

September 30, 2009

Study Description

The purpose of this study is to determine the safety and efficacy of acupuncture as a complementary therapy to pain medication for joint pain associated with aromatase inhibitors for breast cancer treatment. Breast cancer patients are living longer largely due to the benefits of hormonal therapy. Aromatase inhibitors (AIs) are a new class of hormonal agents which block estrogen synthesis in postmenopausal women. However, musculoskeletal pain occurs in up to 50% of patients treated with AIs and often does not respond to conventional pain medications. AI-induced joint pain interferes with patient compliance and may cause major disability. Therefore, safe and effective treatments are needed to alleviate AI-induced musculoskeletal pain.

Acupuncture is a traditional Chinese method of medical treatment and a popular modality for treating musculoskeletal pain. Acupuncture involves the use of thin needles to stimulate specific points of the body and leads to pain control through the release of endorphin in the central nervous system. Clinical trials have found a benefit of acupuncture for the treatment of knee and back pain. Given the lack of effective treatments for AI-induced joint pain and the safety and efficacy of acupuncture, it is therefore reasonable to evaluate whether acupuncture is effective in breast cancer patients who experience musculoskeletal pain related to AIs.

Connect with a study center

Columbia University
New York, New York 10032
United States
Site Not Available

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