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

Trial Summary

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 data supports the effectiveness of this treatment for lockjaw in head and neck cancer patients?

Research shows that using jaw-mobilizing devices, like the Dynasplint Trismus System, can help improve mouth opening in patients with trismus (lockjaw) after head and neck cancer treatment. One study found that patients experienced a 32% increase in mouth opening after using such a device. ^{1 2 3 4 5}

Is the jaw stretching device safe for humans?

The studies reviewed did not report any significant safety concerns or adverse events related to the use of jaw-mobilizing devices for trismus in head and neck cancer patients. ^{1 4 5 6 7}

How does the Trismus Device Prototype treatment differ from other treatments for lockjaw in head and neck cancer patients?

The Trismus Device Prototype is unique because it is a jaw-stretching device specifically designed to help improve mouth opening in patients with lockjaw due to head and neck cancer. Unlike other treatments that may involve medication or manual therapy, this device focuses on mechanically increasing the range of motion in the jaw through regular use. ^{1 3 4 5 8}

What is the purpose of this trial?

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.

Research Team

Andrea Park, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Trismus in head and neck cancer patients in Sweden: incidence and risk factors. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Dynasplint for the management of trismus after treatment of upper aerodigestive tract cancer: a retrospective study. [2019]

4. United States 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. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physiotherapeutic Interventions for Trismus in Head and Neck Cancer: Where Is the Manual Therapy? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Trismus intra-operative release and expansion (TIRE): A novel operative treatment for trismus. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Treating trismus: A prospective study on effect and compliance to jaw exercise therapy in head and neck cancer. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Trismus in head and neck oncology: a systematic review. [2018]