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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Deglutition Disorders; Trismus; Head and Neck Neoplasm
• Intervention / Treatment: Behavioral: Preventive intervention

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Tuomi, PhD; Phone Number: +46313422543; Email: lisa.tuomi@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Esophageal Diseases; Spasm; Head and Neck Neoplasms; Deglutition Disorders; Trismus
• Other Study ID Numbers: 00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No