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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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.
Lauren A Zatarain, MD
United States: Food and Drug Administration
|Vanderbilt University||Nashville, Tennessee 37232-6305|