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

Completed · Not applicable

Conditions studied: Trismus, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT01649583

Run by

Vanderbilt University Medical Center

People needed

40

Starts

2012-08-01

Expected to finish

2014-06-01

Last updated by the study team

2017-04-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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