HNC: Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Preventive intervention 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
Preventive, structured exercise protocol
|
| No Intervention: Control group No intervention, only encouragement to eat and drink for as long as possible during treatment |
Outcome Measures
Primary Outcome Measures
- Maximal Interincisal opening (MIO) [1 month post radiotherapy]
Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening.
- Swallowing ability [1 month after radiotherapy]
Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)
Secondary Outcome Measures
- Trismus and jaw related symptoms [Up to 5 years post radiotherapy]
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.
- Dysphagia related symtoms [Up to 5 years post radiotherapy]
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.
- Health related quality of life (HRQL) [Up to 5 years post radiotherapy]
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.
- Health related quality of life (HRQL) [Up to 5 years post radiotherapy]
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.
- Swallowing ability [Up to 5 years post radiotherapy]
Swallowing ability measured with FEES
- Maximal Interincisal opening (MIO) [Up to 5 years post radiotherapy]
Jaw opening measured in millimeters
Other Outcome Measures
- Cost [Up to 5 years post radiotherapy]
The cost of intervention compared to usual care. Costs in Swedish crowns (SEK) for the intervention and all visits to healthcare during 5 years will be recorded.
- Quality of life for cost-effectiveness analysis [Up to 5 years post radiotherapy]
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
- Quality Adjusted Life Years (QALY) [Up to 5 years post radiotherapy]
QALY is a measurement that combines health-related quality of life (HRQL) and life expectancy in one index. The index range between 0 and 1, where 0 equals death and 1 represents perfect health. Thus, 1 QALY corresponds to 1 year of perfect health. This is calculated using the EQ-5D.
- Incremental Cost Effectiveness Ratio (ICER) [Up to 5 years post radiotherapy]
Incremental cost for each QALY for the intervention group will be calculated using a Markov model which combines the costs and EQ-5D. The ICER will then be compared to the maximum willingness to pay level which is SEK 500,000 (€55,000) according to the Swedish National Board of Health and Welfare.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
-
Receiving radiohterpay (+/- chemotherapy) with curative intent
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No previous trismus or dysphagia
Exclusion Criteria:
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Surgery due to head and neck cancer
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Previous treatment for head and neck cancer
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Tracheostomized patients
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No teeth
-
Inability to perform exercise intervention
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Inability to independently fill out questionnaires in Swedish
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Previous neurologic or neuromuscular disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sahlgrenska University Hospital | Gothenburg | Sweden | 41345 |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00