Efficacy and safety of Dentoxol\xae 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,Eva Bustamante,Sergio Becerra,Sebastián Solé,Alexander Cifuentes,Natalia Jara,Francisco Larsen,Lorena Vargas,Richard Feinn,Claudia Carvajal,Alejandro Santini,Benjamín Martínez,David Rosenberg,Tomas Galván,Jorge Oyarzún,Piero Bettoli,Hernán Letelier

doi:10.1007/s00520-020-05358-4

Abstract

PurposeThe 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.MethodsA 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.ResultsThe 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.ConclusionThe 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.

Highlights

Oral mucositis refers to erythematous and ulcerative lesions of the oral mucosa seen in cancer patients undergoing systemic chemotherapy and/or head and neck radiotherapy.These lesions are painful and compromise nutritional intake and oral hygiene of the patient, which increases the risk for local and systemic infection [1,2,3]
Two large studies in patients treated with radiotherapy for head and neck cancer showed that some degree of oral mucositis occurred in 94–96% of patients in the control group
The secondary objectives were as follows: (1) to determine the effect of Dentoxol® mouthwash on duration of severe oral mucositis, (2) to determine the effect of Dentoxol® mouthwash on pain due to oral mucositis, and (3) to assess the safety of Dentoxol® mouthwash

Summary

Introduction

Oral mucositis refers to erythematous and ulcerative lesions of the oral mucosa seen in cancer patients undergoing systemic chemotherapy and/or head and neck radiotherapy. These lesions are painful and compromise nutritional intake and oral hygiene of the patient, which increases the risk for local and systemic infection [1,2,3]. Patients undergoing radiotherapy for head and neck cancer usually receive approximately 200 cGy daily dose of radiation, 5 days a week, for 5– 7 continuous weeks. Almost all of these patients will develop some degree of oral mucositis. Severe oral mucositis developed in 66% of control group patients in these two studies [4, 5]

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