Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients with Head and Neck Cancer
- Conditions
- TrismusDeglutition DisordersHead and Neck Neoplasm
- Interventions
- Behavioral: Preventive intervention
- Registration Number
- NCT04005521
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
- Receiving radiohterpay (+/- chemotherapy) with curative intent
- No previous trismus or dysphagia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preventive intervention 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Maximal Interincisal opening (MIO) Up to 5 years post radiotherapy Jaw opening measured in millimeters
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
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.
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.
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden