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

NCT05671861 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 22206NCI-2022-10268
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Trismus; Head and Neck Cancer

Keywords

Radiation-related

Outcome Measures

Primary Outcomes (1)

• Mean change in maximum interincisal opening (MIO) over time

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

  Up to 6 weeks

Secondary Outcomes (2)

• Number of participants with device-related adverse events

  Up to 1 year

• Rate of compliance

  Up to 1 year

Study Arms (2)

Part I (medical device usage, questionnaire)

EXPERIMENTAL

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.

Device: Trismus Device Prototype; Other: Questionnaires

Part II (medical device usage, mobile app usage)

EXPERIMENTAL

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.

Device: Trismus Device Prototype; Other: Mobile Application

Interventions

Trismus Device Prototype DEVICE

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

Also known as: Medical Device

Part I (medical device usage, questionnaire); Part II (medical device usage, mobile app usage)

Questionnaires OTHER

Surveys will be administered to participants

Also known as: Survey Administration

Part I (medical device usage, questionnaire)

Mobile Application OTHER

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

Also known as: Mobile App

Part II (medical device usage, mobile app usage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator
• American Academy of Otolaryngology-Head and Neck Surgery Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Trismus; Head and Neck Neoplasms

Interventions

Equipment and Supplies; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea Park, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)