Clinical Trial VICCSUPP1232
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
Principal Investigator(s)
Details
- Protocol No. VICCSUPP1232
- Open Date: 07/17/2012
- Staging: NA
- Age Group: Adults
- Scope: Local
- Objective: To evaluate the feasibility of the use of the Jaw Dynasplint? System in patients undergoing primary or adjuvant radiation-based therapy for head and neck cancer as measured by patient-reported compliance.
- Disease Sites: Head/Neck
- Therapies: Radiotherapy; Supportive Care
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01649583
- Secondary Protocol No: Not Specified
Description
None Provided.
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
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