TrismusNCT05671861
Evaluating a Low-Cost Therapeutic Device in Managing Head and Neck Cancer Patients With Radiation-Related Trismus
A study testing Trismus Device Prototype, Questionnaires and Mobile Application in people with Trismus and Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trismus, Head and Neck Cancer
- What is being tested?
- Trismus Device Prototype, Questionnaires and Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Design of a Low-Cost Therapeutic Device for 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 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Trismus, Head and Neck Cancer
- Being tested
- Trismus Device Prototype, Questionnaires, Mobile Application
- Keywords
- Radiation-related
- Medical subject headings
- Trismus, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trismus Device PrototypeDevice
Also called Medical Device
Device is noninvasive and will be inserted between patient's upper and lower teeth
QuestionnairesOther
Also called Survey Administration
Surveys will be administered to participants
Mobile ApplicationOther
Also called Mobile App
A study-specific, accompanying secure mobile application for users to track progress will be created.
| Study group | Role | What they receive |
|---|---|---|
| Part I (medical device usage, questionnaire) | Experimental | 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. Receives: Device: Trismus Device Prototype; Other: Questionnaires |
| Part II (medical device usage, mobile app usage) | Experimental | 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. Receives: Device: Trismus Device Prototype; Other: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 weeks
Secondary outcomes (2)
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.
Measured: Up to 1 year
Rate of compliance
Percentage of participants who utilize the addition of the study-specific mobile application designed to track participant progress and participant compliance.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start27 Apr 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund, American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- Andrea Park, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671861
- Sponsor's protocol ID
- 22206
- Other IDs
- NCI-2022-10268
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
- ClinicalTrials.gov ID
- NCT05671861
- Acronym / sponsor ID
- 22206
- Conditions
- Trismus, Head and Neck Cancer
- Keywords
- Radiation-related
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund, American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I (medical device usage, questionnaire) | Experimental | Device: Trismus Device Prototype, Other: QuestionnairesEach 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. |
| Part II (medical device usage, mobile app usage) | Experimental | Device: Trismus Device Prototype, Other: Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trismus Device PrototypeAlso: Medical DeviceDevice is noninvasive and will be inserted between patient's upper and lower teeth | Device | Part I (medical device usage, questionnaire), Part II (medical device usage, mobile app usage) |
| QuestionnairesAlso: Survey AdministrationSurveys will be administered to participants | Other | Part I (medical device usage, questionnaire) |
| Mobile ApplicationAlso: Mobile AppA study-specific, accompanying secure mobile application for users to track progress will be created. | Other | Part II (medical device usage, mobile app usage) |
Primary outcome
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
2 secondary outcomes
Number of participants with device-related adverse events
Time frame: Up to 1 year
Rate of compliance
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Park, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trismus Device Prototype, Questionnaires and Mobile Application in people with Trismus and Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in maximum interincisal opening (MIO) over time (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.