Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial

Rajesh V Lalla, Sebastián Solé, Sergio Becerra, Claudia Carvajal, Piero Bettoli, Hernán Letelier, Alejandro Santini, Lorena Vargas, Alexander Cifuentes, Francisco Larsen, Natalia Jara, Jorge Oyarzún, Richard Feinn, Eva Bustamante, Benjamín Martínez, David Rosenberg, Tomas Galván, Rajesh V Lalla, Sebastián Solé, Sergio Becerra, Claudia Carvajal, Piero Bettoli, Hernán Letelier, Alejandro Santini, Lorena Vargas, Alexander Cifuentes, Francisco Larsen, Natalia Jara, Jorge Oyarzún, Richard Feinn, Eva Bustamante, Benjamín Martínez, David Rosenberg, Tomas Galván

Abstract

Purpose: The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer.

Methods: A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed.

Results: The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events.

Conclusion: The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

Keywords: Dentoxol; Head and neck cancer; Mouthrinse; Oral mucositis; Radiation therapy.

Conflict of interest statement

RVL has served as a paid consultant for Ingalfarma SpA, Colgate Oral Pharmaceuticals, Galera Therapeutics, Monopar Therapeutics, Mundipharma, and Sucampo Pharma; has received research support to his institution from Galera Therapeutics, Novartis, Oragenics, and Sucampo Pharma; and has received stock in Logic Biosciences. RF has served as a paid consultant for Ingalfarma SpA. DR and TG have a stock/ownership interest in Ingalfarma SpA. The remaining authors disclosed no conflicts.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Percentage of patients with severe oral mucositis according to the number of doses and treatment group. (Note: There were no patients in the control group who rinsed less than twice/day during week 2)

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Source: PubMed

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