Acupuncture Research Protocol: Feasibility of Use of Acupuncture for Treatment of Arthralgia Secondary to Aromatase Inhibitor Therapy in Women with Early Breast Cancers

摘要

Background: Breast cancer is the most common cancer in females in Australia. Aromatase-inhibitors (AIs) are recommended as adjuvant hormone therapy for postmenopausal women with early breast cancer. A substantial proportion of women taking AIs experience joint pain and stiffness. This AI induced arthralgia does not respond to conventional analgesics and can greatly reduce a woman's quality of life. Studies have suggested that acupuncture may be effective in treating osteoarthritis. Method: This is a randomised double blind phase 2 pilot trial. Participants will be randomised to receive sham or electroacupuncture (EA). Participants in the real electroacupuncture group will receive electroacupuncture twice weekly for six weeks. Patients in the placebo group will receive sham electroacupuncture for the same duration of time via specially designed non-skin penetrating needles placed at points close to the real acupuncture points in the study. Outcomes of joint pain and stiffness will be measured with BPI-SF, WO MAC, quality of life and cognitive function with FACT-G, FACT-Cog, hand strength by a grip test, and serum markers of inflammation (CRP) by a blood test. Discussion: In this article, we report the acupuncture pilot study protocol and design of a randomised clinical trial to reduce joint pain caused by chemotherapy. We expect this pilot study will provide information about the potential efficacy of acupuncture on arthralgia caused by aromatase inhibitor chemotherapy for women with breast cancer. Further, if this study's results are positive, the data will be used to support grant applications to conduct a large RCT to provide the scientific evidence of acupuncture on arthralgia. Trial registration: This clinical trial obtained ethics approval from the Royal Prince Alfred Hospital, Sydney and is registered with The Australian New Zealand Clinical Trials Registry (ANZCTR).