Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Objective assessment of the swallowing function (dysphagia) at regular intervals
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Objective assessment of the swallowing function (dysphagia) at regular intervals
Time Frame: 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 )
Subjective assessment of the swallowing function (dysphagia) at regular intervals
Time Frame: 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).
Secondary Outcomes
- local control(6 months)