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

Primary Purpose

Trismus, Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trismus Device Prototype
Questionnaires
Mobile Application
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Trismus focused on measuring Radiation-related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part I (medical device usage, questionnaire)

Part II (medical device usage, mobile app usage)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2023
Last Updated
September 11, 2023
Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05671861
Brief Title
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
Official Title
Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus, Head and Neck Cancer
Keywords
Radiation-related

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part I (medical device usage, questionnaire)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part II (medical device usage, mobile app usage)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Trismus Device Prototype
Other Intervention Name(s)
Medical Device
Intervention Description
Device is noninvasive and will be inserted between patient's upper and lower teeth
Intervention Type
Other
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Survey Administration
Intervention Description
Surveys will be administered to participants
Intervention Type
Other
Intervention Name(s)
Mobile Application
Other Intervention Name(s)
Mobile App
Intervention Description
A study-specific, accompanying secure mobile application for users to track progress will be created.
Primary Outcome Measure Information:
Title
Mean change in maximum interincisal opening (MIO) over time
Description
The mean change in MIO from baseline to end of treatment at 6 weeks will be reported
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Number of participants with device-related adverse events
Description
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.
Time Frame
Up to 1 year
Title
Rate of compliance
Description
Percentage of participants who utilize the addition of the study-specific mobile application designed to track participant progress and participant compliance.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Park, MD
Phone
877-827-3222
Email
Andrea.Park@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Park, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Park, MD
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Andrea Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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