Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE)

未提供0 个研究点目标入组 40 人开始时间: 2022年6月15日最近更新: 2025年1月31日

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 40
主要终点: The amount of change in the maximum tongue pressure value

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 85age old under（—）
性别: All

入选标准

•Patients with oropharynx or hypopharynx cancer (regardless of tissue system) who undergo chemoradiation treatment or radiation treatment as the first curative treatment. But, patients who have undergone chemotherapy prior to chemoradiation treatment or radiation treatment are included.
•Age: 18 to 85 years old
•Performance Status (ECOG) is 0 or 1 (within one month prior to obtaining consent)
•Patients with written consent for participation of this clinical study from the patient or its representative

排除标准

•Patients whose don't recognize measurer's instructions (e.g. patients with dementia, aphasia, aphasia, higher brain dysfunction, intellectually disabled, etc.)
•Patients who can't grip the tongue pressure probe with the front teeth (e.g. patients who are toothless jaws and are not wearing dentures)
•Patients who can't crush the tongue pressure probe (e.., patients who cannot move the tongue at all)
•Patients with dysphagia du to the pretreatment for head and neck cancer
•Patients with significant decrease in swallowing function due to a history of central diseases, etc.
•Other patients who are judged inadequate to this research by the principal (sub) investigator

结局指标

主要结局

The amount of change in the maximum tongue pressure value

时间窗: before radiation treatment and 3 months after the end of treatment (Before treatment is defined as the time from obtaining informed consent to the start of radiation treatment. After treatment is at the time 3 months plus and minus 14 days after the end of radiation treatment).

The maximum tongue pressure value is the maximum value in the 3 times mesurement.

次要结局

Evaluation by swallowing endoscopy(each point)
Swallowing disorder findings by swallowing imaging examination(each point)
The amount of change in the maximum tongue pressure value(1 month after the start of radiation treatment and 0, 1, or 6 months after the end of treatment)

研究者

发起方

未提供

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