Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania Abramson Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- >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
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Low-level laser therapy
Single arm
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Low-level laser therapy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Consented and Enrolled in Study
大体时间：Approximately 5-month recruitment window
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Number of participants who consented the study and number of participants who enrolled in the study
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Approximately 5-month recruitment window
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Number of Participants Completed the Study Visits
大体时间：Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
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Number of participants who completed the study visits
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Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
|
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Number of Participants With Adverse Events
大体时间：Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
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Number of participants who experienced adverse events during the course of the study.
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Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
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Number of Participants Who Were Satisfied With Study Intervention.
大体时间：at 4-week post-intervention visit
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Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).
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at 4-week post-intervention visit
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Low-Level Laser的临床试验
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Tulane UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Vanderbilt... 和其他合作者完全的