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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671861
• Other study ID #: 22206
• Secondary ID: NCI-2022-10268
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Arushi Gulati, MD
• Phone: 877-827-3222
• Email: Arushi.Gulati[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: March 31, 2028
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Trismus

Intervention

Device:
• Trismus Device Prototype
Device is noninvasive and will be inserted between patient's upper and lower teeth

Other:
• Questionnaires
Surveys will be administered to participants
• Mobile Application
A study-specific, accompanying secure mobile application for users to track progress will be created.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mount Zion Health Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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