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Status unknownNCT04597177Updated Sep 20, 2021

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

An interventional study of ST-IMRT SW-IMRT in Swallowing Dysfunction, sponsored by National Cancer Institute, Egypt. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-20.

Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Sep 2015, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Swallowing Dysfunction
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 146 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
146 participants (actual)

Study arms

  • Active comparator
    ST-IMRT

    standard parotid sparing IMRT

    Radiation: ST-IMRT SW-IMRT

  • Experimental
    SW-IMRT

    swallowing sparing IMRT

    Radiation: ST-IMRT SW-IMRT

Interventions

  • RadiationST-IMRT SW-IMRT
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months

  2. 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 )

    Time frame: 6 months

Secondary outcomes

  1. local control

    Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence

    Time frame: 6 months

07

Study locations

1 site
  • May Ashour
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04597177
Lead sponsor
National Cancer Institute, Egypt
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Sep 1, 2015
Primary completion
Nov 30, 2016
Completion
Dec 30, 2022 (estimated)
Last update
Sep 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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