Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.

Official Title
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Preventive Randomized Study Regarding Jaw- and Swallowing Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Trismus, Swallowing Function and Quality of Life

Conditions
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Head and Neck Neoplasm, Trismus, Deglutition Disorders

Intervention / Treatment
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* Behavioral: Preventive intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx) Receiving radiohterpay (+/- chemotherapy) with curative intent No previous trismus or dysphagia Exclusion Criteria: Surgery due to head and neck cancer Previous treatment for head and neck cancer Tracheostomized patients No teeth Inability to perform exercise intervention Inability to independently fill out questionnaires in Swedish Previous neurologic or neuromuscular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive intervention<br>Patient will perform daily exercise: jaw and swallwing exercises, as well as are encouraged to eat and drink for as long as possible during treatment | Behavioral: Preventive intervention<br>* Preventive, structured exercise protocol<br>|
| No Intervention: Control group<br>No intervention, only encouragement to eat and drink for as long as possible during treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Interincisal opening (MIO) | Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening. | 1 month post radiotherapy | 
| Swallowing ability | Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES) | 1 month after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus and jaw related symptoms | Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms. | Up to 5 years post radiotherapy | 
| Dysphagia related symtoms | PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome. | Up to 5 years post radiotherapy | 
| Health related quality of life (HRQL) | Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL. | Up to 5 years post radiotherapy | 
| Health related quality of life (HRQL) | Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL. | Up to 5 years post radiotherapy | 
| Swallowing ability | Swallowing ability measured with FEES | Up to 5 years post radiotherapy | 
| Maximal Interincisal opening (MIO) | Jaw opening measured in millimeters | Up to 5 years post radiotherapy |