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Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical oral Omega-3 hydrogel group | Experimental | Patients will be given topical oral Omega-3 hydrogel |
|
| Conventional preventive treatment group | Active Comparator | Patients will be given conventional preventive treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical oral Omega-3 hydrogel | Drug | Topical oral Omega-3 hydrogel prepared from fish oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Mucositis Severity | Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Alexandria University | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| conventional preventive treatment | Drug | topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash. Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed) |
|