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

NCT ID: NCT05671861

Condition: Trismus
Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Trismus

Conditions: Keywords:
Radiation-related

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Trismus Device Prototype
Description: Device is noninvasive and will be inserted between patient's upper and lower teeth
Arm group label: Part I (medical device usage, questionnaire)
Arm group label: Part II (medical device usage, mobile app usage)

Other name: Medical Device

Intervention type: Other
Intervention name: Questionnaires
Description: Surveys will be administered to participants
Arm group label: Part I (medical device usage, questionnaire)

Other name: Survey Administration

Intervention type: Other
Intervention name: Mobile Application
Description: A study-specific, accompanying secure mobile application for users to track progress will be created.
Arm group label: Part II (medical device usage, mobile app usage)

Other name: Mobile App

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Contact:
Last name: Arushi Gulati, MD

Phone: 877-827-3222
Email: Arushi.Gulati@ucsf.edu

Contact backup:
Email: cancertrials@ucsf.edu

Investigator:
Last name: Andrea Park, MD
Email: Principal Investigator

Start date: December 30, 2024

Completion date: March 31, 2028

Lead sponsor:
Agency: University of California, San Francisco
Agency class: Other

Collaborator:
Agency: Mount Zion Health Fund
Agency class: Other

Source: University of California, San Francisco

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05671861

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