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

Sahlgrenska University Hospital

Status: Active, not recruiting

Conditions: Head and Neck Neoplasm; Deglutition Disorders; Trismus

Treatments: Behavioral: Preventive intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04005521

00

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Preventive intervention

Experimental group

Description:

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

Treatment:

Behavioral: Preventive intervention

Control group

No Intervention group

Description:

No intervention, only encouragement to eat and drink for as long as possible during treatment