NCT01351376已完成不适用
The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Arm Volume
研究概览
简要总结
This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
- •stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
- •girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment
- •able to commit to a long term follow-up schedule
排除标准
- •active cancer/metastatic cancer
- •currently receiving or have plans for adjuvant radiation or chemotherapy
- •presence of other extremity lymphedema (primary or secondary)
- •pacemaker
- •artificial joints in the upper quadrants
- •renal failure
- •arterial insufficiency
- •congestive heart failure
- •chronic inflammatory conditions
- •history of deep vein thrombosis (DVT) in the lymphedematous upper extremity
- •previous treatment with Low Level Laser (regardless of indication)
- •medication(s) known to affect body fluid balance
- •body mass index (BMI) > 40 (morbid obesity)
研究组 & 干预措施
LLL combined with CDT
Active Comparator
CDT + active LLL
干预措施: Low Level Laser (Device)
Placebo
Placebo Comparator
CDT + inactive LLL
干预措施: Low Level Laser Therapy (Device)
结局指标
主要结局
Arm Volume
时间窗: 13 Months
次要结局
- Short-Form Health Survey (SF-36)(13 months)
研究者
研究点 (3)
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