P4-12-13: A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors: First Interim Analysis.

Abstract

Abstract Background: Aromatase inhibitors (AIs) are recommended as first-line adjuvant hormonal therapy in postmenopausal women with hormone-receptor-positive breast cancer, as monotherapy or sequential therapy after tamoxifen. AI-associated musculoskeletal symptoms (AIMSS) occur in approximately 50% of women receiving AIs and in some may result in discontinuation of treatment. Symptom management is essential to ensure that breast cancer patients receive the full recommended duration of AI therapy. We conducted a randomized, placebo-controlled trial to evaluate the effect of acupuncture on AIMSS and report the first interim analysis. Method: Postmenopausal women with early stage breast cancer, experiencing AIMSS, who had not had acupuncture in the year prior to the study, were eligible. Patients were randomized to 8 weekly acupuncture or sham acupuncture. Health assessment questionnaire disability index (HAQ-DI ranging 0–3.0) and pain visual analog scale (VAS ranging 0–100) were used to assess clinical musculoskeletal disorder severity at weeks 0, 4, 8, and 12 or 24. Change in HAQ-DI (ΔHAQ-DI) and VAS scores (ΔVAS) from baseline were compared between patients receiving acupuncture versus sham acupuncture using exact Wilcoxon rank sum test. Serum samples were collected for measurements of estrogens and beta endorphin concentrations and cytokine profile before and after the intervention to evaluate the etiology of AIMSS and the mechanism of acupuncture in treating AIMSS. Results: Between May 2008 and June 2011, 48 patients were enrolled, 2 patients were not evaluable due to noncompliance to treatment and lost to follow up, 10 were still receiving treatment and therefore not evaluable. Thirty-six were evaluable, and were equally distributed between the real and sham acupuncture groups. Baseline characteristics were balanced between the two groups with regard to age, race, and body mass index (BMI) with the exception that baseline mean HAQ-DI was higher in the acupuncture group (0.9 vs 0.55, p=0.04). White/Black/Asian: 26/7/3, Median (range): age: 61 (45-82); BMI (kg/m2): 31.1 (22.9−59.6). At week 8, both groups showed a wide range of ΔHAQ-DI (ΔHAQ-DI =HAQ-DIweek8-HAQ-DIbaseline): from −1.38 to 0.5 in the acupuncture group versus from −1 to 0.12 in sham acupuncture group. There was no statistically significant difference in mean ΔHAQ-DI between the real and sham acupuncture groups (−0.33 vs −0.33, p=0.87). Eleven patients in each group (61%) reported decreased HAQ-DI scores, which correlated with improved function. There was no difference in mean ΔVAS between the real and sham acupuncture groups (−9.27 vs −13.82, p=0.67). No significant side effects were reported. Changes in other time points and in serum biomarkers will be presented at the meeting. Conclusions: The majority of breast cancer patients experiencing AIMSS who participated in our study reported a reduced HAQ-DI score both from acupuncture and sham acupuncture. We did not observe significant differences between responses to real versus sham acupuncture after 8 weekly treatments. The study remains open to accrual to reach 50 evaluable patients. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P4-12-13.