Low Level Laser Treatment and Breast Cancer Related Lymphedema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- LDex Change-
研究概览
简要总结
Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.
详细描述
The purpose of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with related LE. Findings from this pilot randomized study will be used to determine if LLLT has possible value in the treatment of LE and warrants subsequent evaluation in a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Breast cancer survivors will be included if they:
- •are age 21 or older;
- •require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
- •have an order for lymphedema treatment; and
- •are willing and able to drive to the study sites.
排除标准
- •Individuals will not be included if they:
- •are actively undergoing intravenous chemotherapy or radiation therapy;
- •have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
- •are unable to stand upright for measurement of height and weight;
- •have active/metastatic cancer;
- •are pregnant,:
- •have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
- •have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.
结局指标
主要结局
LDex Change-
时间窗: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Whole Arm Volume Difference
时间窗: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
Whole arm measurement to determine volume.
次要结局
- Symptoms(Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.)
- Quality of Life(Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.)
研究者
Sheila Ridner
professor
Vanderbilt University