Clinical trial NCT04005521: Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients with Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasm
Trismus
Deglutition Disorders
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximal Interincisal opening (MIO)
timeFrame: 1 month post radiotherapy
measure: Swallowing ability
timeFrame: 1 month after radiotherapy
Secondary outcomes:
measure: Trismus and jaw related symptoms
timeFrame: Up to 5 years post radiotherapy
measure: Dysphagia related symtoms
timeFrame: Up to 5 years post radiotherapy
measure: Health related quality of life (HRQL)
timeFrame: Up to 5 years post radiotherapy
measure: Health related quality of life (HRQL)
timeFrame: Up to 5 years post radiotherapy
measure: Swallowing ability
timeFrame: Up to 5 years post radiotherapy
measure: Maximal Interincisal opening (MIO)
timeFrame: Up to 5 years post radiotherapy
Other outcomes:
measure: Cost
timeFrame: Up to 5 years post radiotherapy
measure: Quality of life for cost-effectiveness analysis
timeFrame: Up to 5 years post radiotherapy
measure: Quality Adjusted Life Years (QALY)
timeFrame: Up to 5 years post radiotherapy
measure: Incremental Cost Effectiveness Ratio (ICER)
timeFrame: Up to 5 years post radiotherapy
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: Saghafi E, Kadhim K, Andas CA, Cahlin BJ, Finizia C, Axelsson T, Kjeller G, Tuomi L. Jaw exercise in head and neck cancer patients for prevention of temporomandibular disorders: a randomized controlled trial. J Cancer Surviv. 2024 Nov 22. doi: 10.1007/s11764-024-01717-w. Online ahead of print.
citation: Petersson K, Finizia C, Pauli N, Tuomi L. Preventing radiation-induced dysphagia and trismus in head and neck cancer-A randomized controlled trial. Head Neck. 2025 Jan;47(1):159-174. doi: 10.1002/hed.27886. Epub 2024 Aug 1.