NCT05671861

Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus

Active, enrolled NA Last updated 13 January 2026

What this trial tests

NA trial testing Trismus Device Prototype in Trismus in 35 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 April 2023

Primary endpoint
31 May 2027

31 March 2028

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	35
Start date	27 April 2023
Primary completion	31 May 2027
Estimated completion	31 March 2028
Sites	1 location across United States

Drugs / interventions tested

• Trismus Device Prototype
• Questionnaires
• Mobile Application

Conditions studied

• Trismus — all drugs for Trismus →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Trismus or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial evaluates how well a new therapeutic device works in managing trismus in patients who received radiation treatment for head and neck cancer. Radiation therapy is a common form of treatment in patients with head and neck cancers. However, changes to surrounding tissue following radiation therapy may lead to trismus, an inability to open the mouth fully. This can create significant functional impairment leading to malnutrition due to impaired chewing, risk of dental infections due to impaired oral hygiene, difficulty with speech, and decreased health-related quality of life. Exercise therapy is the mainstay of treatment for post-radiation trismus to help improve mobility and flexibility and increase range of mouth opening. This new device is non-invasive and is similar to other jaw stretching devices where a mouthpiece is placed between the teeth and a hand-lever is used to spread open the upper and lower jaw. However, it will also have additional sensors to measure pressure exerted by the hands and jaw as well as the distance to open the mouth which could help guide therapy. This study may help doctors customize a device to patient-specific needs, provide real-time feedback, and encourage compliance for trismus exercise therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.