Therapeutic Device for Lockjaw in Head and Neck Cancer Patients

Overseen By Arushi Gulati, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Minors, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Trismus Device Prototype, designed to assist individuals with trismus, a condition that restricts mouth opening after radiation treatment for head and neck cancer. Trismus can impact eating, speaking, and oral hygiene. The device resembles a jaw stretcher but includes sensors to track pressure and mouth opening, guiding therapy. The trial seeks participants who struggle to open their mouths due to past radiation treatments. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those affected by trismus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapeutic device is safe for managing trismus in head and neck cancer patients?

Research has shown that jaw stretching devices, like the one under testing, are generally safe. In a study with a similar device called Restorabite™, most participants completed the treatment without major issues. Only 6 out of 120 participants did not finish, suggesting the device is well-tolerated.

Another study examined different devices for treating trismus and found that people could easily incorporate them into their daily routines. This indicates they could follow the treatment plan, which is a positive sign of safety and comfort.

Overall, evidence indicates that these devices are safe to use. They are non-invasive, meaning they don't require surgery or anything entering the body. Most people can use them without problems, making them a promising option for those dealing with trismus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trismus device prototype because it offers a hands-on approach to treating lockjaw, a condition often seen in head and neck cancer patients. Unlike standard treatments that might focus on medication or surgery, this device is used directly by patients, providing them with a more active role in their recovery. The device, used in conjunction with a mobile app, not only helps track progress but also encourages consistent use, which could lead to better long-term outcomes. This combination of a physical device and digital tracking is a novel approach that brings a new level of engagement and personalization to trismus treatment.

What evidence suggests that this device is effective for managing trismus?

Research has shown that jaw-stretching devices can help treat trismus, a condition that limits mouth opening and often affects head and neck cancer patients after radiation. One study found that devices like TheraBite® can increase Maximal Interincisal Opening (MIO). Another study examined various devices and found that applying pressure to the jaw can improve mouth opening for those with trismus. In this trial, participants will use a new trismus device prototype, which incorporates sensors to measure pressure and distance, potentially offering more personalized and effective treatment. Early signs suggest this could guide therapy and improve outcomes for patients with trismus. ^{2 4 5 6 7}

Who Is on the Research Team?

Andrea Park, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with radiation-induced trismus, a condition where the mouth can't fully open (MIO < 35 mm), after head and neck cancer treatment. Participants must be able to give consent and follow study requirements. It's not for minors or those who can't consent, or if there's a risk to their safety or data quality.

Inclusion Criteria

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

I have trouble opening my mouth wide due to past radiation treatment on my head or neck.

Exclusion Criteria

I am over 18 and can make my own medical decisions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part I: Device Testing and Questionnaire

Participants complete a single 45-minute visit to test a prototype of the trismus therapy device and complete questionnaires about features important to them in trismus treatment.

1 day

1 visit (in-person)

Part II: Exercise Therapy

Participants undergo exercise therapy with the trismus device under supervision of a speech language pathologist, using the device at least three times per week and up to daily for 15-20 minutes over 6 weeks.

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up visit 7 days after completion.

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Trismus Device Prototype

Trial Overview The trial tests a new therapeutic device designed to manage trismus in patients treated with radiation for head and neck cancers. The device helps stretch the jaw while measuring pressure and opening distance, aiming to improve mouth mobility and encourage exercise therapy adherence.

How Is the Trial Designed?

Group I: Part II (medical device usage, mobile app usage) Experimental Treatment 2 Interventions

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.

Group II: Part I (medical device usage, questionnaire) Experimental Treatment 2 Interventions

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.

Trismus Device Prototype is already approved in United States for the following indications:

Approved in United States as Trismus Device Prototype for:

• Radiation-related trismus in head and neck cancer patients

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Mount Zion Health Fund

Collaborator

Trials

13

Recruited

930+

Published Research Related to This Trial

The Trismus Intra-operative Release and Expansion (TIRE) procedure showed significant immediate improvement in interincisal distance (IID) by an average of 18.44 mm in patients with trismus due to head and neck cancer, indicating its efficacy right after treatment.

While TIRE provided initial relief from trismus, the sustained improvement was not consistently maintained beyond one year, suggesting that while it can facilitate further therapeutic options, long-term benefits may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trismus intra-operative release and expansion (TIRE): A novel operative treatment for trismus. Shih, MC., Gudipudi, R., Nguyen, SA., et al.[2023]

In a study involving 50 patients with head and neck cancer over a 10-week period, both the TheraBite and Engström jaw exercise devices significantly improved mouth opening, with increases of 7.2 mm (22.9%) and 5.5 mm (17.6%) respectively.

The greatest improvements in mouth opening and exercise compliance occurred in the first four weeks, indicating that early intervention may be crucial for maximizing benefits in reducing trismus-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating trismus: A prospective study on effect and compliance to jaw exercise therapy in head and neck cancer. Pauli, N., Andréll, P., Johansson, M., et al.[2016]

The Dynasplint Trismus System (DTS) effectively increased the maximal incisal opening (MIO) in patients with trismus due to head and neck cancer, with a mean improvement of 32% from 19.3 mm to 25.5 mm over the treatment period.

The most significant improvement occurred in the first 6 weeks, with an initial rate of gain of 0.36 mm/day, indicating that early intervention with DTS is crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynasplint for the management of trismus after treatment of upper aerodigestive tract cancer: a retrospective study. Barañano, CF., Rosenthal, EL., Morgan, BA., et al.[2019]

In a study of 69 head and neck cancer patients, 42% developed trismus (reduced jaw mobility) after treatment, with the highest incidence in those treated for parotid gland tumors and nasopharyngeal cancers.

Patients who developed trismus had larger tumors, poorer physical function before treatment, and often received higher radiation doses (over 50 Gy), indicating that these factors may increase the risk of trismus following radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trismus in head and neck cancer patients in Sweden: incidence and risk factors. Johnson, J., van As-Brooks, CJ., Fagerberg-Mohlin, B., et al.[2010]

The dynamic jaw opening device (DTS) significantly improved the maximal interincisal distance (MID) in patients with head and neck cancer-related trismus, increasing from 16.5 mm to 23.5 mm (P<.001) when used as part of a multimodal treatment approach.

Patients who adhered to the DTS treatment recommendations showed even greater improvement, with MID increasing from 16 mm to 27 mm (P<.001), highlighting the importance of compliance in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary report on the efficacy of a dynamic jaw opening device (dynasplint trismus system) as part of the multimodal treatment of trismus in patients with head and neck cancer. Stubblefield, MD., Manfield, L., Riedel, ER.[2022]

In a study of 27 head and neck cancer patients, both the TheraBite® and Dynasplint stretching devices showed minimal improvement in maximal mouth opening after 3 months, with increases of 3.0 mm and 1.5 mm respectively, indicating limited efficacy for both devices.

Patients faced significant challenges with the stretching exercises, including pain, fitting issues, and overall health deterioration, which should be considered when recommending similar rehabilitation protocols for trismus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial. van der Geer, SJ., Reintsema, H., Kamstra, JI., et al.[2022]

The scoping review of nine studies found that while jaw-mobilizing devices may help manage trismus in head and neck cancer survivors, they did not show effectiveness in preventing trismus.

There is a need for more research led by physical therapists to explore the potential benefits of manual therapy for trismus, as current studies indicate poor adherence and completion rates among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physiotherapeutic Interventions for Trismus in Head and Neck Cancer: Where Is the Manual Therapy? Nedeljak, J., Armijo-Olivo, S., Hernandez, IA., et al.[2023]

Radiotherapy affecting the temporomandibular joint and pterygoid muscles can lead to a significant reduction in mouth opening (average decrease of 18%), highlighting a common risk factor for trismus in head and neck cancer patients.

Interventions such as exercises with a therabite device and tongue blades have been shown to significantly improve mouth opening, with effect sizes of 2.6 and 1.5 respectively, indicating their potential efficacy in treating trismus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trismus in head and neck oncology: a systematic review. Dijkstra, PU., Kalk, WW., Roodenburg, JL.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6892373/

The use of stretching devices for treatment of trismus in ... In a randomized controlled trial, we compared the effects of the TheraBite and the DTS on mouth opening in head and neck cancer patients with trismus.

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05671861

Low-Cost Therapeutic Device in Managing Head and Neck ... This trial evaluates how well a new therapeutic device works in managing trismus in patients who received radiation treatment for head and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837522000173

Trismus therapy devices: A systematic review Trismus devices which use the application of force to the jaw can improve the MIO of patients with established trismus.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ijc.34941

Restorabite™: Phase II trial of jaw stretching exercises ... This phase II clinical trial evaluated whether a new portable device using regulated, incremental force, Restorabite™ is a safe and effective ...

5. atosmedical.com atosmedical.com/wp-content/uploads/sites/2/2023/06/MC3028-ThEN_202306-TheraBite-LitReview.pdf

TheraBite® Jaw Motion Rehabilitation System™ In summary, for HNC patients suffering from trismus, the TheraBite® has been shown to be efficient in treating trismus and increasing Maximal Interincisal.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38556848/

Restorabite™: Phase II trial of jaw stretching exercises ... Safety, adherence, changes in mouth opening, and patient-reported outcomes are presented. 114/120 participants with trismus completed the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144678/

Amplification, Resistance, and Kinetics of the Jaw ... The ARK-JSD is a low-cost trismus device that can force between 12.3 and 32.7 N. The variation in resistance may impact efficacy.