Acupuncture for Aromatase Inhibitor Induced Joint Pain
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Orthopedic |
| Therapuetic Areas: | Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 11/8/2017 |
| Start Date: | June 2005 |
| End Date: | September 2009 |
Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients
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.
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.
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.
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.
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 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
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
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