TrismusNCT01649583
Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer
A study testing Jaw Dynasplint System in people with Trismus and Head and Neck Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Trismus, Head and Neck Cancer
- What is being tested?
- Jaw Dynasplint System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven head and neck cancer
- Planned primary or adjuvant radiation treatment with 50cGy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment
- Patients receiving induction or concurrent chemotherapy
- Baseline interincisoral distance > 35 mm
- Willing and able to provide informed consent
- Sufficient manual dexterity to utilize the device
- All participants must be at least 21 years of age
Who cannot join
- Patients with collagen vascular disorders that may predispose to radiation fibrosis
- Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Evaluate Use of the Jaw Dynasplint System to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy
The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.
Read the detailed description
Data suggest that early intervention with mechanical stretching devices for head and neck cancer patients undergoing curative therapy maximizes their effectiveness in the treatment of trismus. That being said, treatment for trismus typically begins after head and neck cancer patients are found to have moderate to severe reduction in jaw range of motion. Typically, clinicians will begin therapy when the IID is 3.0 cm or less. A subset of head and neck cancer patients will develop severe or rapidly progressive trismus that will fail to respond to treatment. In this cohort, trismus may lead to permanent, severe morbidity. It may be hypothesized that preventative strategies that encourage routine stretching during and immediately after the completion of cancer therapy may prevent or minimize trismus. No studies have examined the prophylactic use of the Jaw Dynasplint® System during cancer treatment.
Furthermore, it is not known whether patients can tolerate wearing a mechanical stretching device during treatment. The investigators would like to test the hypothesis that: 1) preventive use of a mechanical stretching device during cancer treatment and early recovery is feasible, and 2) preventive use of a mechanical stretching device will result in a marked decrease in the incidence and severity of trismus in patients undergoing primary or adjuvant radiation therapy for head and neck cancer.
- Conditions
- Trismus, Head and Neck Cancer
- Being tested
- Jaw Dynasplint System
- 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.
Jaw Dynasplint SystemDevice
Also called Trismus Dynasplint, Mechanical Stretching Device
Patients on the intervention arm will wear the Jaw Dynasplint® System for 30 minutes, 3 times per day each day during the cancer treatment period and for the first 3 months after primary or adjuvant based-radiation treatment (recovery period) is completed. Patients will maintain a daily patient log indicating the amount of time they used the Jaw Dynasplint® System.
| Study group | Role | What they receive |
|---|---|---|
| Jaw Dynasplint System | Experimental | Not described Receives: Device: Jaw Dynasplint System |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients
Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.
Measured: 2 years
Secondary outcomes (1)
Preliminary Efficacy Data on Prevention of Trismus
Interincisoral distance (IID) will be the primary measure of efficacy. Any patient who develops IID of 30 mm or less will be considered to have clinically significant trismus. The incidence of trismus will be compared between the intervention arm (Arm 1) and the standard of care arm (Arm 2).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
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 Vanderbilt University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Zatarain, Vanderbilt University Medical Center
- Investigators
- Lauren A Zatarain, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649583
- Sponsor's protocol ID
- 120727
- Status last verified
- Mar 2017
- First submitted
- 20 Jul 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Use of the Jaw Dynasplint System to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy
- ClinicalTrials.gov ID
- NCT01649583
- Acronym / sponsor ID
- 120727
- Conditions
- Trismus, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2012 (estimated)
- 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.
The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.
Detailed description
Data suggest that early intervention with mechanical stretching devices for head and neck cancer patients undergoing curative therapy maximizes their effectiveness in the treatment of trismus. That being said, treatment for trismus typically begins after head and neck cancer patients are found to have moderate to severe reduction in jaw range of motion. Typically, clinicians will begin therapy when the IID is 3.0 cm or less. A subset of head and neck cancer patients will develop severe or rapidly progressive trismus that will fail to respond to treatment. In this cohort, trismus may lead to permanent, severe morbidity. It may be hypothesized that preventative strategies that encourage routine stretching during and immediately after the completion of cancer therapy may prevent or minimize trismus. No studies have examined the prophylactic use of the Jaw Dynasplint® System during cancer treatment.
Furthermore, it is not known whether patients can tolerate wearing a mechanical stretching device during treatment. The investigators would like to test the hypothesis that: 1) preventive use of a mechanical stretching device during cancer treatment and early recovery is feasible, and 2) preventive use of a mechanical stretching device will result in a marked decrease in the incidence and severity of trismus in patients undergoing primary or adjuvant radiation therapy for head and neck cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jaw Dynasplint System | Experimental | Device: Jaw Dynasplint System |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically proven head and neck cancer
- Planned primary or adjuvant radiation treatment with 50cGy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment
- Patients receiving induction or concurrent chemotherapy
- Baseline interincisoral distance > 35 mm
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Patients with collagen vascular disorders that may predispose to radiation fibrosis
- Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
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 |
|---|---|---|
| Jaw Dynasplint SystemAlso: Trismus Dynasplint, Mechanical Stretching DevicePatients on the intervention arm will wear the Jaw Dynasplint® System for 30 minutes, 3 times per day each day during the cancer treatment period and for the first 3 months after primary or adjuvant based-radiation treatment (recovery period) is completed. Patients will maintain a daily patient log indicating the amount of time they used the Jaw Dynasplint® System. | Device | Jaw Dynasplint System |
Primary outcome
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients
Time frame: 2 years
Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.
1 secondary outcome
Preliminary Efficacy Data on Prevention of Trismus
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Lauren A Zatarain, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jaw Dynasplint System in people with Trismus and Head and Neck Cancer, run by Vanderbilt University Medical Center 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 7 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: finished, as of the sponsor's last update on 4 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients (time frame: 2 years). 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 4 Apr 2017.