Multi Center Lymphedema Treatment Registry (LET) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Limb Volume
研究概览
简要总结
Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, Ultrasonography (USG), Indocyanine Green (ICG) Lymphograph or magnetic resonance imaging (MRI)) before and after the complete decongestive therapy. Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.
详细描述
Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, USG, ICG or MRI) before and after the complete decongestive therapy (CDT). Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.
Group 1: CDT Group 2: CDT + PO ketoprofen +Local ketoprofen gel Group 3: CDT + Local ketoprofen gel
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer
- •Lymphedema more than 6 months
- •Lymphedema stage 0-2
- •Completed treatment (CT-RT)
排除标准
- •Stage 3 lymphedema
- •Cardiovasculary disease
- •Hepatic disease
- •Kidney disease
- •Cerebrovascular event
- •Metastasis
- •Gastritis
- •Infection
- •Active cancer
- •Bleeding history
研究组 & 干预措施
Group 2
Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel
干预措施: Ketoprofen (Drug)
Group 3
Complete Decongestive Therapy + Local Ketoprofen gel
干预措施: Ketoprofen (Drug)
结局指标
主要结局
Limb Volume
时间窗: 6,12,18, 24 months
Volume measurements will take using ulnar styloid process as a index point, and circumferential measurements will take with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm is calculate and record before and after the treatment for both arms. All patients' measurements before and after complete decongestive therapy will take by the same researcher. Volume changes will be evaluated at the 6th, 12th, 18th and 24.th months.
次要结局
- Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM)(6,12,18, 24 months)