Curcumin for Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors - The CurPain Trial: A Randomized, Double-Blind, Phase III, Multicenter Clinical Trial

Introduction: Adjuvant treatment with aromatase inhibitors (AIs) is extremely important in hormone-positive breast cancer survivors, reducing the early recurrence of the disease. Arthralgia and musculoskeletal symptoms resulting from AIs-toxicity can be observed in approximately one-third of the treated patients and are the leading cause of AIs-treatment discontinuation. However, there is no sufficient standard treatment. Analgesic and anti-inflammatory effects of curcumin in chronic joint pain are reported. This study protocol will determine whether curcumin supplementation reduces joint pain in breast cancer survivors under AIs therapy. Methods: This study protocol is a phase III, randomized, blinded, placebo-controlled, multicentric, parallel arm design. The study population targets post-menopause women with stage I, luminal, unilateral, non-metastatic, receptor-positive breast cancer after breast-conserving surgery healed per primary intention. 160 participants will be enrolled. Daily curcumin supplementation (500 mg thrice daily) for twelve weeks is planned. Brief Pain Inventory-Worst Pain (Δ BPI-WP) will assess joint pain change after twelve weeks of follow-up as the primary outcome. Secondary outcomes include Quality of Life assessed by Functional Assessment of Cancer Therapy-Breast, further Brief Pain Inventory-Short Form items, Patient Health Questionnaire-8, and Quantitative Analgesic Questionnaire at six and twelve weeks. Discussion: We present a randomized clinical trial to provide scientific evidence that supports the efficacy of curcumin supplementation on joint pain alleviation, pain-relieving medication reduction, and AIs-treatment adherence improvement in a predefined breast cancer survivor population.