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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trismus, Head and Neck Cancer

Intervention / Treatment
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* Device: Trismus Device Prototype
* Other: Questionnaires
* Other: Mobile Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I (medical device usage, questionnaire)<br>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<br>* Device is noninvasive and will be inserted between patient's upper and lower teeth<br>* Other names: Medical Device;Other: Questionnaires<br>* Surveys will be administered to participants<br>* Other names: Survey Administration;|
| Experimental: Part II (medical device usage, mobile app usage)<br>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<br>* Device is noninvasive and will be inserted between patient's upper and lower teeth<br>* Other names: Medical Device;Other: Mobile Application<br>* A study-specific, accompanying secure mobile application for users to track progress will be created.<br>* Other names: Mobile App;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with device-related adverse events | 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. | Up to 1 year | 
| Rate of compliance | Percentage of participants who utilize the addition of the study-specific mobile application designed to track participant progress and participant compliance. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation-related