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

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Michaela Apostolou
Tina Méry
Ivan Aivasovsky
Milena Akamatsu
Marianna Daibes
Winifer Araujo
Maria Burgos
Victor Capellan
Fabiana Cerulli
Vitor Costa
Wilson Fandino
Igor Farias
Vivian Gagliardi
Maria Gomez
David Guardamino
Andreina Guzman
Karla Loss
Sabah Mohamed
Veronica Montero
Javier Obeso
Alicia Rosell
Jorge Sakon
Erik Simon
Rene Tovar
Samuel Afonseca
Katarzyna Kresse-Walczak

Abstract




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 (∆ 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.




Article Details

How to Cite
Curcumin for Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors - The CurPain Trial: A Randomized, Double-Blind, Phase III, Multicenter Clinical Trial. (2023). Principles and Practice of Clinical Research, 9(2). https://doi.org/10.21801/ppcrj.2023.92.10
Section
Clinical Research Design

How to Cite

Curcumin for Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors - The CurPain Trial: A Randomized, Double-Blind, Phase III, Multicenter Clinical Trial. (2023). Principles and Practice of Clinical Research, 9(2). https://doi.org/10.21801/ppcrj.2023.92.10

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