Oral Mucositis
Conditions
Keywords
Mucositis
Brief summary
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.
Interventions
DEVICEDentoxol
Mouthrinse
DEVICEPlacebo
Mouthrinse
Sponsors
Ingalfarma SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy. * Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity
Exclusion criteria
* Unable to give written informed consent * Known allergy/intolerance to any component of the study rinse or placebo * Planning to use any contraindicated medications during the study period (pain medications are allowed) * Age below 18 years * Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale | First day of radiation therapy through last day of radiation therapy (5-8 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale. | 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). | 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). | 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. | 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. | First day of radiation therapy through last day of radiation therapy (5-8 weeks) |
Countries
Chile
Outcome results
None listed