An interventional study of Preventive intervention in Head and Neck Neoplasm, Trismus and Deglutition Disorders, sponsored by Sahlgrenska University Hospital. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Prevention
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 80 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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
No intervention, only encouragement to eat and drink for as long as possible during treatment
Preventive, structured exercise protocol
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters. A MIO \<36 mm is considered as trismus. i.e. limited jaw-opening.
Time frame: 1 month post radiotherapy
Swallowing ability
Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)
Time frame: 1 month after radiotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years post radiotherapy
Swallowing ability
Swallowing ability measured with FEES
Time frame: Up to 5 years post radiotherapy
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters
Time frame: Up to 5 years post radiotherapy
Cost
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.
Time frame: Up to 5 years post radiotherapy
Quality of life for cost-effectiveness analysis
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
Time frame: Up to 5 years post radiotherapy
Quality Adjusted Life Years (QALY)
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.
Time frame: Up to 5 years post radiotherapy
Incremental Cost Effectiveness Ratio (ICER)
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.
Time frame: Up to 5 years post radiotherapy
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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