Effect of Tart Cherry on Aromatase Inhibitor-Induced Arthralgia (AIA) in Nonmetastatic Hormone-Positive Breast Cancer Patients: A Randomized Double-Blind Placebo-Controlled Trial.

Abstract Background: Aromatase inhibitors (AI) are the standard treatment for hormone receptor‐positive breast cancer in postmenopausal women. About half of patients taking AI suffer Aromatase Inhibitor Arthralgia (AIA) which can cause noncompliance. Suboptimal AI adherence is associated with decreased survival. Effective AIA interventions are limited. In clinical trials, tart cherry (TC) showed beneficial effect on musculoskeletal pain associated with osteoarthritis, gout, and strenuous exercise. The flavonoids and anthocyanins in TC reportedly exert an anti-inflammatory effect, which may lessen the adverse effects of estrogen deficiency. This trial aimed to investigate whether TC can reduce AIA in non-metastatic hormone positive breast cancer (NMHPBC) patients. Methods: Randomized, placebo-controlled, double-blind trial. Eligible patients with NMHPBC on AI for at least 4 weeks were randomized to TC concentrate [50 tart cherries] versus placebo (P) [syrup] in 1:1 model. Patients instructed to consume 1 Oz of concentrate in 8 Oz water daily for 6 weeks, and document their pain intensity at baseline, weekly and at study completion in a diary using Visual Analog Scale (VAS), with 0 mm indicating no pain, and 100 mm indicating highest pain. Results: 60 Patients were enrolled. 2 patients did not complete the study due to diarrhea, and 10 patients were non-compliant. 48 patients were included in the final analysis. TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts). This difference was statistically significant (Mann-Whitney U Test P = 0.034). Conclusions: Tart cherry can significantly improve AIA in non-metastatic breast cancer patient