Curcumin for Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors - The CurPain Trial: A Randomized, Double-Blind, Phase III, Multicenter Clinical Trial
Authors:   Department of Obstetrics and Gynecology, Hospital Chemnitz, Chemnitz, Germany, Apostolou Michaela , Mery Tina ,   Children’s Hospital Chemnitz, Chemnitz, Germany, Aivasovsky Ivan ,   Beth Israel Deaconess Medical Center, Cardiology Department - Harvard Medical School, Boston, USA, Akamatsu Milena ,   Instituto Butantan, São Paulo, SP, Brazil, Daibes Marianna ,   Clínica Cláudio Domênico, Rio de Janeiro, RJ, Brazil, Araujo Winifer ,   Universidad Autónoma de Santo Domingo, Santo Domingo, Dominican Republic, Burgos Maria ,   Tecnoquimicas, Cali, Colombia, Capellan Victor ,   Grupo Yunen, Santo Domingo, Dominican Republic, Cerulli Fabiana ,   Hospital Alemão Oswaldo Cruz, São Paulo-SP, Brazil, Costa Vitor ,   Samaritano Paulista Hospital, São Paulo-SP, Brazil, Fandino Wilson ,   St Thomas’ Hospital, London, United Kingdom, Farias Igor ,   AC Camargo Cancer Center, São Paulo-SP, Brazil, Gagliardi Vivian ,   Hospital Israelita Albert Einstein, São Paulo, SP, Brazil, Gomez Maria ,   Pontificia Universidad Catolica Madre y Maestra (PUCMM), Santiago, Dominican Republic, Guardamino David ,   Beth Israel Deaconess Medical Center, Guzman Andreina ,   Dominican Red Cross, Santo Domingo, Dominican Republic, Loss Karla ,   Children’s Hospital Los Angeles, Los Angeles, USA, Mohamed Sabah ,   Hamad Medical Corporation, Doha, Qatar, Montero Veronica ,   University of Southern California, Institute of Urology, Keck School of Medicine, Los Angeles, CA, USA, Obeso Javier ,   Plataforma INVEST Medicina UANL - KER Unit Mayo Clinic (KER Unit Mexico), Monterrey, N.L., Mexico, Rosell Alicia ,   Hospital de Pediatría Juan P. Garrahan, CABA, Argentina, Sakon Jorge ,   Hospital Alemão Oswaldo Cruz, São Paulo-SP, Brazil, Simon Erik ,   University Hospital Dresden - Neurology Department, Dresden, Germany, Tovar Rene ,   University of San Martin de Porres, Lima, Peru, Afonseca Samuel ,   Grupo de Oncologia da Bahia, Feira de Santana, Bahia, Brazil, Kresse-Walczak Katarzyna ,   Department of Prosthetic Dentistry, Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
Published: August 2023

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.