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

NCT01649583 | Completed

• 1 other identifier: 120727
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Trismus; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Preliminary Efficacy Data on Prevention of Trismus

  2 years

Other Outcomes (1)

• Symptom Burden of Patients with Trismus

  2 years

Study Arms (2)

Jaw Dynasplint System

EXPERIMENTAL

Device: Jaw Dynasplint System

Control Arm

NO INTERVENTION

Interventions

Jaw Dynasplint System 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.

Also known as: Trismus Dynasplint, Mechanical Stretching Device

Jaw Dynasplint System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Trismus; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Lauren A Zatarain, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)