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Swallowing Rehabilitation Program for Head and Neck Tumor Patients

ConditionHead and Neck Cancer (H&N)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorDelta University for Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both genders

Aged 20-60 years

Patients receiving chemoradiotherapy

Patients having a history of head and neck cancer

Disqualifiers

Patients who had neurological or psychiatric problems

Patients who had dysphagia for a reason other than cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Swallowing Rehabilitation Program

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Swallowing Rehabilitation ProgramExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
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).

Time frame
Baseline and 6 weeks after initiation of the swallowing rehabilitation program

Other outcomes

1

Change in Pain Level as Measured by the Numerical Pain Scale (NPS)

Pain level assessed using the Numerical Pain Scale (NPS), ranging from 0 to 10, with higher scores indicating greater pain severity (0 = none, 1-3 = mild, 4-6 = moderate, 7-10 = severe pain).

Time frame
Baseline and 6 weeks after initiation of the swallowing rehabilitation program

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Delta University for Science and Technology

Lead sponsor

National Cancer Institute, Cairo

Collaborator

Clinical Oncology department. Elmansoura University.

Collaborator

Source ClinicalTrials.gov
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