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ACTIVE NOT RECRUITING
NCT05671861
NA

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2023-04-27

Completion Date

2028-03-31

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States