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NCT05671861 · ClinicalTrials.gov registry record · NA
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
A NA study of Head and Neck Cancer and Trismus, sponsored by University of California, San Francisco.
- Active
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05671861: Active NA study of Head and Neck Cancer and Trismus, sponsored by University of California, San Francisco.
NCT05671861 is a NA study of Head and Neck Cancer and Trismus that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 35 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05671861, a NA study of Head and Neck Cancer and Trismus, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The mean change in MIO from baseline to end of treatment at 6 weeks will be reported
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Mobile Application
- DEVICE Trismus Device Prototype
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What the registry record for NCT05671861 still lists
NCT05671861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Questionnaires is the first listed.
NCT05671861 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05671861 about?
NCT05671861 is a clinical study titled "Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus". 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 t...
What is the current status of trial NCT05671861?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2023-04-27. Estimated completion is 2028-03-31.
What conditions does trial NCT05671861 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Trismus.
What interventions are being tested in trial NCT05671861?
The interventions under investigation include: Questionnaires (OTHER), Mobile Application (OTHER), Trismus Device Prototype (DEVICE).
Who is sponsoring clinical trial NCT05671861?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05671861 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05671861's enrollment target sits among peer trials
35 165th of 250 higher than 83 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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