Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Internal lymphedema measurement
研究概览
简要总结
The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.
详细描述
Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan
- •Both male and females
- •18 to 100 years of age
排除标准
- •Significant surgical resection of pharyngeal constrictor muscles
- •Patients with persistent or recurrent disease
- •Patients who have contraindications to use Flexitouch Plus device
结局指标
主要结局
Internal lymphedema measurement
时间窗: 2 hours
The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device).
次要结局
- External lymphedema measurement(2 hours)