Swallowing DysfunctionNCT04597177
SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer
A study testing ST-IMRT SW-IMRT in people with Swallowing Dysfunction, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Dysfunction
- What is being tested?
- ST-IMRT SW-IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2015to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
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.
- Conditions
- Swallowing Dysfunction
- Being tested
- ST-IMRT SW-IMRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-IMRT SW-IMRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| ST-IMRT | Active comparator | standard parotid sparing IMRT Receives: Radiation: ST-IMRT SW-IMRT |
| SW-IMRT | Experimental | swallowing sparing IMRT Receives: Radiation: ST-IMRT SW-IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 )
Measured: 6 months
Secondary outcomes (1)
local control
Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Sep 2015
- Primary completion30 Nov 2016
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597177
- Sponsor's protocol ID
- MD201001409.3
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04597177
- Acronym / sponsor ID
- MD201001409.3
- Conditions
- Swallowing Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-IMRT | Active comparator | Radiation: ST-IMRT SW-IMRTstandard parotid sparing IMRT |
| SW-IMRT | Experimental | Radiation: ST-IMRT SW-IMRTswallowing sparing IMRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-IMRT SW-IMRT | Radiation | ST-IMRT, SW-IMRT |
Primary outcome
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).
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 )
1 secondary outcome
local control
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ST-IMRT SW-IMRT in people with Swallowing Dysfunction, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessment of the swallowing function (dysphagia) at regular intervals (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.