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To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.
Patients are randomly assigned to either ST-IMRT or SW-IMRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-IMRT | Active Comparator | standard parotid sparing IMRT |
|
| SW-IMRT | Experimental | swallowing sparing IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-IMRT SW-IMRT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of the swallowing function (dysphagia) at regular intervals | Subjective assessment of swallowing function (dysphagia) will be scored on a scale of 0 (no dysphagia) to 4 (life threatening consequences; urgent intervention indicated) each follow-up visit on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE 4). | 6 months |
| Objective assessment of the swallowing function (dysphagia) at regular intervals | Objective assessment of swallowing will be made by videofluoroscopy and scored by Dynamic Imaging Grade of swallowing toxicity scale (DIGEST) and will be scored on a scale of 0 (no dysphagia) to 4 (life threatening ) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| local control | Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| May Ashour | Cairo | Egypt |
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