- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05671861
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arushi Gulati, MD
- Phone Number: 877-827-3222
- Email: Arushi.Gulati@ucsf.edu
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of California, San Francisco
-
Principal Investigator:
- Andrea Park, MD
-
Contact:
- Email: cancertrials@ucsf.edu
-
Contact:
- Arushi Gulati, MD
- Phone Number: 877-827-3222
- Email: Arushi.Gulati@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part I (medical device usage, questionnaire)
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 is noninvasive and will be inserted between patient's upper and lower teeth
Other Names:
Surveys will be administered to participants
Other Names:
|
Experimental: Part II (medical device usage, mobile app usage)
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 is noninvasive and will be inserted between patient's upper and lower teeth
Other Names:
A study-specific, accompanying secure mobile application for users to track progress will be created.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
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.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrea Park, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22206
- NCI-2022-10268 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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