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A Randomized Controlled Trial Assessing The Effect Of Acupuncture In Reducing Aromatase Inhibitor Associated Musculoskeletal Symptoms
Breast cancer is the most common cancer and the second most common cause of cancer death among women in the United States. Two-thirds of invasive breast cancers are hormone-receptor -positive and require long-term adjuvant hormonal therapy. Aromatase inhibitors (AIs) are the recommended first-line adjuvant hormonal therapy in postmenopausal women with hormone-receptor?positive breast cancer, either as monotherapy or sequential therapy after tamoxifen. Studies have demonstrated that musculoskeletal symptoms in users of AIs are common and may be severe. Up to 13% of patients discontinue their AI as a result of musculoskeletal symptoms. The currently available treatment for AI-associated musculoskeletal symptoms is unsatisfactory. Symptom management is essential in order to ensure that breast cancer patients receive the full recommended duration of AI therapy. The efficacy of acupuncture for pain control has been demonstrated in patients with a variety of conditions, including lower back pain, osteoarthritis, and carpal tunnel syndrome, and a single-arm pilot study in 21 women on AIs reported that acupuncture decreased joint pain and stiffness and resulted in less analgesic use. Animal research suggests that acupuncture accomplishes its anesthetic effect by altering neurohormonal pathways to release neurotransmitters, such as endorphins, and by inhibiting release of inflammatory cytokines. Acupuncture has also been reported to relieve menopausal symptoms and improve quality of life.
We hypothesize that acupuncture will reduce AI-associated musculoskeletal symptoms and menopausal symptoms and improve quality of life significantly compared with sham acupuncture. We propose to randomly assign 100 women suffering from AI-associated musculoskeletal symptoms to 8 weekly sessions of acupuncture or sham acupuncture. All patients will receive usual medical care in addition to the study intervention. Health assessment questionnaire disability index (HAQ-DI) will be used to assess clinical musculoskeletal disorder severity before and after acupuncture treatment at weeks 0, 4, 8, and 24. Change in HAQ-DI score will be compared between women on AIs receiving acupuncture versus sham acupuncture. This difference will be correlated with change in oral analgesic use and the proportion of patients who change or discontinue AI therapy in each group (Aim #1). At weeks 0, 4, 8, and 24, patients will complete menopausal symptom and quality of life questionnaires to compare changes in menopausal symptoms and overall quality of life between patients receiving acupuncture versus sham acupuncture (Aim 2). Serum estrogen and beta endorphin concentrations and cytokine profile will be assessed before and after treatment to evaluate the etiology of AI-associated musculoskeletal symptoms and the mechanism of acupuncture in treating AI-associated musculoskeletal symptoms (Aim 3).
Our long term goal is to identify an effective non-pharmacological treatment for AI-associated musculoskeletal symptoms that would permit a greater percentage of early-stage breast cancer patients to receive optimal adjuvant hormonal therapy.
One in seven women in the United States will develop breast cancer in her lifetime. Among them, two thirds will have hormone-receptor-positive breast cancer and will benefit from taking hormonal therapy. Aromatase inhibitors (AIs) are now an integral part of hormonal therapy for postmenopausal women with hormone-receptor-positive breast cancer. Although AIs decrease the risk of breast cancer recurrence and improve survival, they cause joint and muscle discomfort in up to 50% of women, which results in treatment discontinuation in up to 13%. The current treatment for AI associated musculoskeletal symptoms is limited and unsatisfactory. It is important to find a safe and effective treatment to help breast cancer patients to be able to tolerate the recommended duration of AI treatment. Acupuncture is an ancient medical technique that is popular, safe, and effective in treating musculoskeletal pain. A previous study of twenty-one women on AIs reported acupuncture decreased their joint pain and stiffness, and lowered their use of pain medication. Here we examine this observation more rigorously and hypothesize that acupuncture can reduce musculoskeletal symptoms caused by AIs.
We have designed a clinical trial that will randomly assign patients to receive 8 weekly acupuncture treatments or 8 weekly fake acupuncture treatments. We will assess patients? response to acupuncture treatment through questionnaires about pain, menopausal symptoms, and ability to conduct their usual activities. We hypothesize that acupuncture works through changing the level of hormones and cytokines in the body. To better understand how acupuncture works, we will also measure the patient?s estrogen, cytokine, and endorphin concentrations before and after acupuncture treatment.
Our study has the potential to identify an effective non-pharmacological treatment for AI- associated joint and muscle discomfort. Our long-term goal is to identify an acupuncture regimen that will allow breast cancer patients to tolerate the full recommended course of adjuvant AI treatment.