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

NCT ID: NCT05671861

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2028-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Part I (medical device usage, questionnaire)

Each participant will complete a single 45-minute visit in which consists of questionnaires about features that are important to them in trismus treatment, test a prototype of a trismus therapy device, and complete an online feedback questionnaire about their experience using the device.

Group Type: EXPERIMENTAL

Trismus Device Prototype

Intervention Type: DEVICE

Device is noninvasive and will be inserted between patient's upper and lower teeth

Questionnaires

Intervention Type: OTHER

Surveys will be administered to participants

Part II (medical device usage, mobile app usage)

Participants will be asked to use the device at least three times per week and up to daily for a period of 15-20 minutes over 6 weeks. Participants will be evaluated at baseline, at the 3-week (halfway) visit, and at the end of the 6-week treatment period under supervision of a speech language pathologist on study. Participants will then utilize a mobile app to help track treatment progress.

Group Type: EXPERIMENTAL

Trismus Device Prototype

Intervention Type: DEVICE

Device is noninvasive and will be inserted between patient's upper and lower teeth

Mobile Application

Intervention Type: OTHER

A study-specific, accompanying secure mobile application for users to track progress will be created.

Interventions

Trismus Device Prototype

Device is noninvasive and will be inserted between patient's upper and lower teeth

Intervention Type: DEVICE

Questionnaires

Surveys will be administered to participants

Intervention Type: OTHER

Mobile Application

A study-specific, accompanying secure mobile application for users to track progress will be created.

Intervention Type: OTHER

Other Intervention Names

Medical Device; Survey Administration; Mobile App

Eligibility Criteria

Inclusion Criteria

• Male or female >= 18 years of age at visit 1.
• Documentation of a radiation-induced trismus diagnosis as evidenced by one or more clinical features consistent with the trismus phenotype (maximum interincisal opening (MIO) < 35 mm) and a history of head and neck radiation
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria

• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
• Minors (age < 18 years) or patients with inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Zion Health Fund

OTHER

Sponsor Role: collaborator

American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Park, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2022-10268

Identifier Type: REGISTRY

Identifier Source: secondary_id

22206

Identifier Type: -

Identifier Source: org_study_id