The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
108
Clinica IRAM
Santiago, Chile
Fundación Arturo López Pérez
Santiago, Chile
Instituto Nacional del Cáncer
Santiago, Chile
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Weight loss, as measured by the difference between weight on first and last day of radiation therapy.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
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