Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participants Who Were Satisfied With Study Intervention.
研究概览
简要总结
The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.
详细描述
Primary aim:
To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Completion of either postoperative radiation or chemoradiation therapy
- •No evidence of cancer
- •Having head and neck external lymphedema
- •Either completion of lymphedema therapy or not in active lymphedema therapy
- •Ability to speak and read English
- •Able to provide informed consent
排除标准
- •Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.
结局指标
主要结局
Number of Participants Who Were Satisfied With Study Intervention.
时间窗: at 4-week post-intervention visit
Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).
Number of Participants Completed the Study Visits
时间窗: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of participants who completed the study visits
Number of Participants With Adverse Events
时间窗: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of participants who experienced adverse events during the course of the study.
Number of Participants Consented and Enrolled in Study
时间窗: Approximately 5-month recruitment window
Number of participants who consented the study and number of participants who enrolled in the study
次要结局
未报告次要终点
研究者
Jie Deng
Associate Professor, PhD
University of Pennsylvania