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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lauren Zatarain, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01649583
First received: July 20, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Trismus
Head and Neck Cancer
Device: Jaw Dynasplint System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.


Secondary Outcome Measures:
  • Preliminary Efficacy Data on Prevention of Trismus [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Symptom Burden of Patients with Trismus [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Patient reported outcome data will be collected via questionnaires including, the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey version 2.0 (VHNSS v2.0 plus GSS), and the Mandibular Function Impairment Questionnaire (MFIQ). This patient reported outcome data will be collected in order to identify correlations between trismus and symptom burden.


Estimated Enrollment: 40
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jaw Dynasplint System Device: Jaw Dynasplint System
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.
Other Names:
  • Trismus Dynasplint
  • Mechanical Stretching Device
No Intervention: Control Arm

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649583

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Lauren A Zatarain, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Lauren Zatarain, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01649583     History of Changes
Other Study ID Numbers: 120727
Study First Received: July 20, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Trismus
Neoplasms by Site
Neoplasms
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014