Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer
|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|
- 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.
- 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).
- 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.
|Study Start Date:||August 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|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.
|No Intervention: Control Arm|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649583
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Lauren A Zatarain, MD||Vanderbilt University|