Head and Neck Cancer (H&N)SREP-HNCNCT07795294
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
A study testing Swallowing Rehabilitation Program in people with Head and Neck Cancer (H&N), run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- Swallowing Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2026to 25 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Aged 20-60 years
- Patients receiving chemoradiotherapy
- Patients having a history of head and neck cancer
- Patients who had received previous radiation therapy for head and neck cancer
Who cannot join
- Patients who had neurological or psychiatric problems
- Patients who had dysphagia for a reason other than cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute, Cairo University
Cairo
Islam Mohammed Madian Khalil, 00201145333153, islam.madian@deltauniv.edu.eg
About this study
Official title: Evaluation of a Structured Swallowing Rehabilitation Exercise Program on Dysphagia and Trismus in Head and Neck Tumor Patients
This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Eighty patients will be randomly allocated into two equal groups: a study group receiving the swallowing rehabilitation program and a control group receiving standard care.
Read the detailed description
The swallowing rehabilitation program is a structured intervention designed to improve swallowing ability, mouth opening, and jaw mobility in patients with head and neck tumors. It includes the Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily. The program is delivered across four phases (assessment, planning, implementation, and evaluation) over structured orientation, theoretical, and practical sessions. Outcomes are assessed using the EAT-10 (swallowing function) and the Gothenburg Trismus Questionnaire 2 / GTQ2 (trismus severity), in addition to pain level, at baseline and 6 weeks after initiation of the program.
- Conditions
- Head and Neck Cancer (H&N)
- Being tested
- Swallowing Rehabilitation Program
- Keywords
- Dysphagia, Trismus, Swallowing Rehabilitation, Deglutition Disorders, Head and Neck Cancer, EAT-10, Gothenburg Trismus Questionnaire
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing Rehabilitation ProgramBehavioural
A structured program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily, delivered through orientation, theoretical, and practical sessions.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing Rehabilitation Program | Experimental | Participants will receive a structured swallowing rehabilitation program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises. Exercises will be performed as three sets of ten repetitions, twice daily, delivered across orientation, theoretical, and practical sessions over four phases (assessment, planning, implementation, evaluation). Receives: Behavioral: Swallowing Rehabilitation Program |
| Standard Care | No intervention | Patients receive routine standard care with no structured rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10)
Swallowing function assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item self-administered questionnaire with total scores ranging from 0 to 40, with higher scores indicating greater swallowing difficulty (0-3 = normal swallowing, ≥4 = possible dysphagia, 10-20 = moderate dysphagia, >20 = severe dysphagia).
Measured: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Secondary outcomes (1)
Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2)
Trismus severity assessed using the Gothenburg Trismus Questionnaire 2 (GTQ-2), a 20-item questionnaire with total scores ranging from 24 to 120, with higher scores indicating greater trismus severity (24 = no trismus, 25-57 = mild, 58-89 = moderate, 90-120 = severe trismus).
Measured: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start31 Aug 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies 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
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Cairo, Clinical Oncology department. Elmansoura University.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795294
- Sponsor's protocol ID
- MU-Nurs-HNC-1249
- Acronym
- SREP-HNC
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Structured Swallowing Rehabilitation Exercise Program on Dysphagia and Trismus in Head and Neck Tumor Patients
- ClinicalTrials.gov ID
- NCT07795294
- Acronym / sponsor ID
- SREP-HNC / MU-Nurs-HNC-1249
- Conditions
- Head and Neck Cancer (H&N)
- Keywords
- Dysphagia, Trismus, Swallowing Rehabilitation, Deglutition Disorders, Head and Neck Cancer, EAT-10, Gothenburg Trismus Questionnaire
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- National Cancer Institute, Cairo, Clinical Oncology department. Elmansoura University.
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 31 Aug 2026 (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.
This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Eighty patients will be randomly allocated into two equal groups: a study group receiving the swallowing rehabilitation program and a control group receiving standard care.
Detailed description
The swallowing rehabilitation program is a structured intervention designed to improve swallowing ability, mouth opening, and jaw mobility in patients with head and neck tumors. It includes the Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily. The program is delivered across four phases (assessment, planning, implementation, and evaluation) over structured orientation, theoretical, and practical sessions. Outcomes are assessed using the EAT-10 (swallowing function) and the Gothenburg Trismus Questionnaire 2 / GTQ2 (trismus severity), in addition to pain level, at baseline and 6 weeks after initiation of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swallowing Rehabilitation Program | Experimental | Behavioral: Swallowing Rehabilitation ProgramParticipants will receive a structured swallowing rehabilitation program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises. Exercises will be performed as three sets of ten repetitions, twice daily, delivered across orientation, theoretical, and practical sessions over four phases (assessment, planning, implementation, evaluation). |
| Standard Care | No intervention | –Patients receive routine standard care with no structured rehabilitation program. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders
- Aged 20-60 years
- Patients receiving chemoradiotherapy
- Patients having a history of head and neck cancer
- Patients who had received previous radiation therapy for head and neck cancer
Key exclusion criteria (2 listed)
- Patients who had neurological or psychiatric problems
- Patients who had dysphagia for a reason other than cancer
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 |
|---|---|---|
| Swallowing Rehabilitation ProgramA structured program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily, delivered through orientation, theoretical, and practical sessions. | Behavioural | Swallowing Rehabilitation Program |
Primary outcome
Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10)
Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Swallowing function assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item self-administered questionnaire with total scores ranging from 0 to 40, with higher scores indicating greater swallowing difficulty (0-3 = normal swallowing, ≥4 = possible dysphagia, 10-20 = moderate dysphagia, >20 = severe dysphagia).
1 secondary outcome
Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2)
Time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing Rehabilitation Program in people with Head and Neck Cancer (H&N), run by Delta University for Science and Technology 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10) (time frame: Baseline and 6 weeks after initiation of the swallowing rehabilitation program). 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 7 Oct 2026.