Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer

Not Applicable

Completed

• Conditions: Trismus; Head and Neck Cancer
• Interventions: Device: Jaw Dynasplint System

• Registration Number: NCT01649583
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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. 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 Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Study Start: 2012-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with histologically proven head and neck cancer
2. 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
3. Patients receiving induction or concurrent chemotherapy
4. Baseline interincisoral distance > 35 mm
5. Willing and able to provide informed consent
6. Sufficient manual dexterity to utilize the device
7. All participants must be at least 21 years of age

Exclusion Criteria

1. Patients with collagen vascular disorders that may predispose to radiation fibrosis
2. Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaw Dynasplint System	Jaw Dynasplint System	-

Primary Outcome Measures

Name	Time	Method
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients	2 years	Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.

Secondary Outcome Measures

Name	Time	Method
Preliminary Efficacy Data on Prevention of Trismus	2 years	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).

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States