Head and Neck Cancer (H&N)
Conditions
Keywords
Dysphagia, Trismus, Swallowing Rehabilitation, Deglutition Disorders, Head and Neck Cancer, EAT-10, Gothenburg Trismus Questionnaire
Brief 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. 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.
Interventions
BEHAVIORALSwallowing Rehabilitation Program
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.
Sponsors
Delta University for Science and Technology
National Cancer Institute, Cairo
Clinical Oncology department. Elmansoura University.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients who had neurological or psychiatric problems * Patients who had dysphagia for a reason other than cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2) | Baseline and 6 weeks after initiation of the swallowing rehabilitation program | 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). |
Countries
Egypt
Outcome results
None listed