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NCT Number: NCT05671861

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Trismus Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trismus Device Prototype

Device

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

Other names: Medical Device

questionnaires

Other

Surveys will be administered to participants

Other names: Survey Administration

Mobile application

Other

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

Other names: Mobile App

Primary outcomes

  1. Mean change in maximum interincisal opening (MIO) over time

    Time frame: Up to 6 weeks

    The mean change in MIO from baseline to end of treatment at 6 weeks will be reported

Secondary outcomes

  1. Number of participants with device-related adverse events

    Time frame: Up to 1 year

    During the study, research staff consisting of trained speech language pathologists will monitor patients undergoing exercise therapy for any adverse events. Adverse events for the eligible population will include the number of patients for whom the event occurred by the severity and relationship to study device. Adverse event rates will be coded by body system and Medical Dictionary for Regulatory Activities (MedDRA) classification term and graded using the CTCAE grading scale of (1) Mild to (5) Death.

  2. Rate of compliance

    Time frame: Up to 1 year

    Percentage of participants who utilize the addition of the study-specific mobile application designed to track participant progress and participant compliance.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Academy of Otolaryngology-Head and Neck Surgery Foundation
  • Mount Zion Health Fund

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 5, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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