Study of Dentoxol® Mouthrinse for Oral Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer

Conditions
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Oral Mucositis

Intervention / Treatment
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* Device: Dentoxol
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dentoxol<br>Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. Subjects will use Dentoxol® mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. | Device: Dentoxol<br>* Mouthrinse<br>|
| Placebo Comparator: Placebo<br>The placebo rinse will be identical in color, taste and consistency as the Dentoxol rinse and will be packaged in identical bottles with the same labels. Subjects will use placebo mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. | Device: Placebo<br>* Mouthrinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucositis