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Behavioural Intervention

Therapeutic Device for Lockjaw in Head and Neck Cancer Patients

N/A

Recruiting

Led By Andrea Park, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Minors (age < 18 years) or patients with inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device to help head & neck cancer patients manage trismus, an inability to fully open the mouth. It aims to provide better feedback & encourage exercise therapy to improve mobility & flexibility.

Who is the study for?

This trial is for adults over 18 with radiation-induced trismus, a condition where the mouth can't fully open (MIO < 35 mm), after head and neck cancer treatment. Participants must be able to give consent and follow study requirements. It's not for minors or those who can't consent, or if there's a risk to their safety or data quality.

What is being tested?

The trial tests a new therapeutic device designed to manage trismus in patients treated with radiation for head and neck cancers. The device helps stretch the jaw while measuring pressure and opening distance, aiming to improve mouth mobility and encourage exercise therapy adherence.

What are the potential side effects?

Since this is a non-invasive mechanical device used for physical therapy, side effects may include discomfort from stretching the jaw muscles or potential strain on the temporomandibular joint during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have trouble opening my mouth wide due to past radiation treatment on my head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am over 18 and can make my own medical decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in maximum interincisal opening (MIO) over time

Secondary study objectives

Number of participants with device-related adverse events

Rate of compliance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part II (medical device usage, mobile app usage)Experimental Treatment2 Interventions

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 II: Part I (medical device usage, questionnaire)Experimental Treatment2 Interventions

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.

0 / 2Eligibility criteria met