SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer

Swallowing Dysfunction Clinical Trial

Official title:

Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04597177
• Other study ID #: MD201001409.3
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.

Description:

Patients are randomly assigned to either ST-IMRT or SW-IMRT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Swallowing Dysfunction

Intervention

Radiation:
• ST-IMRT SW-IMRT

Locations

Country	Name	City	State
Egypt	May Ashour	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	local control	Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence	6 months