NCT05671861

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

Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the clinical efficacy of the trismus device, as measured by the change in maximum interincisal opening over the six-week treatment period. SECONDARY OBJECTIVE: I. To assess participants compliance rates and jaw opening pressures when using this device. OUTLINE: Participants are assigned to 1 of 2 parts. PART I: Participants test the trismus device and complete questionnaires on study. PART II: Participants undergo exercise therapy with the trismus device under supervision of a speech language pathologist on study. Participants will be on study for up to 6 weeks with a follow-up visit 7 days after completion.

Conditions

• Trismus
• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Trismus Device Prototype	Device is noninvasive and will be inserted between patient's upper and lower teeth
OTHER	Questionnaires	Surveys will be administered to participants
OTHER	Mobile Application	A study-specific, accompanying secure mobile application for users to track progress will be created.

Timeline

• Start date: 2023-04-27
• Primary completion: 2027-05-31
• Completion: 2028-03-31
• First posted: 2023-01-05
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study