Swallowing Dysfunction
Conditions
Brief summary
To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.
Detailed description
Patients are randomly assigned to either ST-IMRT or SW-IMRT.
Interventions
RADIATIONST-IMRT SW-IMRT
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.
Exclusion criteria
* Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective assessment of the swallowing function (dysphagia) at regular intervals | 6 months | 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). |
| Objective assessment of the swallowing function (dysphagia) at regular intervals | 6 months | 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 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control | 6 months | Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence |
Countries
Egypt
Outcome results
None listed