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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Oct 24, 2022; 13(10): 813-821
Published online Oct 24, 2022. doi: 10.5306/wjco.v13.i10.813
Published online Oct 24, 2022. doi: 10.5306/wjco.v13.i10.813
Clinical relevance of the use of Dentoxol® for oral mucositis induced by radiotherapy: A phase II clinical trial
Sebastián Solé, Lorena Vargas, Francisco Larsen, Natalia Jara, Department of Radiotherapy, Radiomedicine Institute, Américo Vespucio Norte 1314 Vitacura, 7630370, Santiago, Chile
Sergio Becerra, Claudia Carvajal, Alexander Cifuentes, National Institute of Cancer, Santiago, Servicio de Salud Metropolitano Norte, Av Profesor Zañartu 1010, Independencia, 8380455, Santiago, Chile
Piero Bettolli, Eva Bustamante, Oncologic Institute Arturo López Pérez Foundation, José Manuel Infante 805, Providencia, 7500691, Santiago, Chile
Hernán Letelier, Jorge Oyarzún, Hospital Base Valdivia, Bueras 1003 s/n XIV Región, 5100238, Valdivia, Chile
Alejandro Santini, Oncologic Center of Antofagasta, Los Pumas 10255, Antofagasta, 1267348, Antofagasta, Chile
Benjamín Martínez, Universidad Mayor, Santiago, Av Libertador Bernardo O´Higgins 2013, 8340585, Santiago, Chile
David Rosenberg, Tomas Galván, Ingalfarma, Dr Manuel Barros Borgoño 71, Oficina 1308, Providencia, 7500593, Santiago, Chile
Author contributions: Solé S contributed to the conception, design, investigation, supervision, clinical data acquisition, and interpretation and critically revised the manuscript; Becerra S, Carvajal C, Bettolli P, Letelier H, Santini A, Vargas L, Cifuentes A, Larsen F, Jara N, Oyarzún J, and Bustamante E contributed to the conception, investigation, and clinical data acquisition; Martínez B and Galván T contributed to critically revising the manuscript; Rosenberg D contributed to the investigation and interpretation and drafted the manuscript.
Institutional review board statement: The study was reviewed and approved by the Chilean Institute of Public Health.
Clinical trial registration statement: ClinicalTrials.gov Identifier, No. NCT02885376.
Informed consent statement: All the participants have read and understood the provided information and have had the opportunity to ask questions. All authors understand that their participation is voluntary and that they were free to withdraw at any time, without giving a reason and without cost. All authors understand that they will be given a copy of this consent statement.
Conflict-of-interest statement: Rosenberg D and Galván T have a stock/ownership interest in Ingalfarma SpA. The authors declare that they have no conflicts of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sebastián Solé, MD, Assistant Professor, Department of Radiotherapy, Radiomedicine Institute, Américo Vespucio Norte 1314 Vitacura, 7630370, Santiago Chile, Santiago, Chile. sebasole@gmail.com
Received: March 16, 2022
Peer-review started: March 16, 2022
First decision: July 12, 2022
Revised: July 22, 2022
Accepted: September 21, 2022
Article in press: September 21, 2022
Published online: October 24, 2022
Processing time: 217 Days and 8.6 Hours
Peer-review started: March 16, 2022
First decision: July 12, 2022
Revised: July 22, 2022
Accepted: September 21, 2022
Article in press: September 21, 2022
Published online: October 24, 2022
Processing time: 217 Days and 8.6 Hours
Core Tip
Core Tip: Oral mucositis associated with cancer therapy is a frequent complication. Dentoxol® is a medical solution that has been shown to prevent severe oral mucositis. The clinical significance of Dentoxol® was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers. The data obtained show that the clinical impact of Dentoxol® on oral mucositis justifies its incorporation into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis.