Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Total Severity of External Lymphedema and Fibrosis (LEF)
研究概览
简要总结
The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.
详细描述
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.
Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •>6 months post HNC treatment
- •No evidence of cancer confirmed with imaging tests
- •Having head and neck lymphedema with or without fibrosis
- •Completion of initial lymphedema therapy
- •Lymphedema duration between 3-24 months
- •Ability to speak and read English
- •Ability 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
- •Acute infection
- •Photosensitivity
- •Chronic inflammatory diseases
- •Venous thrombosis
- •Carotid artery stenosis
- •History of severe trauma
- •Medication that affects body fluid and electrolyte balance
- •Use of high doses of non-steroidal anti-inflammatory drugs
- •Pre-existing skin rash, ulceration, open wound in the treatment area
- •Active lymphedema therapy or physical therapy
- •Allergic and other systemic skin diseases
结局指标
主要结局
Total Severity of External Lymphedema and Fibrosis (LEF)
时间窗: Baseline, 8-week post-intervention visit
Head and Neck Lymphedema and Fibrosis Assessment Criteria Change in total severity of external LEF from baseline to 8-week post-intervention visits. A larger change in this score means more reduction in the severity of external LEF. External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).
次要结局
- Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale(Baseline, 8-week post-intervention visit)
- Neck Range of Motion Degree: Right Lateral Rotation(Baseline, 8-week post-intervention visit)
- Quality of Life Score: Feeding Tube(Baseline, 8-week post-intervention visit)
研究者
Jie Deng
Associate Professor, PhD
University of Pennsylvania