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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


N/A
21 Years
N/A
Open (Enrolling)
Both
Trismus, Head and Neck Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients

Outcome Description:

Feasibility will be measured based on patient compliance, adverse events, and barriers to use of the Jaw Dynasplint® System.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Lauren A Zatarain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Food and Drug Administration

Study ID:

120727

NCT ID:

NCT01649583

Start Date:

August 2012

Completion Date:

July 2014

Related Keywords:

  • Trismus
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Trismus

Name

Location
Vanderbilt University Nashville, Tennessee  37232-6305