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临床试验/NCT01649583
NCT01649583已完成不适用

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

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Feasibility of use of a Dynasplint during chemoradiation for head and neck cancer patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with histologically proven head and neck cancer
  • 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
  • Patients receiving induction or concurrent chemotherapy
  • Baseline interincisoral distance > 35 mm
  • Willing and able to provide informed consent
  • Sufficient manual dexterity to utilize the device
  • All participants must be at least 21 years of age

排除标准

  • Patients with collagen vascular disorders that may predispose to radiation fibrosis
  • Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation

结局指标

主要结局

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

时间窗: 2 years

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

次要结局

  • Preliminary Efficacy Data on Prevention of Trismus(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Zatarain

MD

Vanderbilt University Medical Center

研究点 (2)

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