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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentoxol | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentoxol | Device | Mouthrinse |
| |
| Placebo |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastián Sole | Clinica IRAM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica IRAM | Santiago | Chile | ||||
| Fundación Arturo López Pérez |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Device |
Mouthrinse |
|
| 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) |
| Santiago |
| Chile |
| Instituto Nacional del Cáncer | Santiago | Chile |
| D004066 |
| Digestive System Diseases |