Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT05671861
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2023-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-10268 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |