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

Deglutition Disorders Clinical Trial

— HNC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04005521
• Other study ID #: 00
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: July 31, 2028

Study information

• Verified date: September 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Trismus

Intervention

Behavioral:
• Preventive intervention
Preventive, structured exercise protocol

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 5 years post radiotherapy
Other	Quality of life for cost-effectiveness analysis	The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).	Up to 5 years post radiotherapy
Other	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.	Up to 5 years post radiotherapy
Other	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.	Up to 5 years post radiotherapy
Primary	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
Primary	Swallowing ability	Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)	1 month after radiotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Swallowing ability	Swallowing ability measured with FEES	Up to 5 years post radiotherapy
Secondary	Maximal Interincisal opening (MIO)	Jaw opening measured in millimeters	Up to 5 years post radiotherapy