Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- CLUE score
研究概览
简要总结
This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Unilateral lymphedema of the arm after mastectomy for breast cancer
排除标准
- •Bilateral lymphedema
- •Primary bone tumor and/or metastasis
- •Patients with ongoing radiotherapy
- •Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
- •Patients with infectious lymphedema/elephantiasis
- •Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
- •Carcinomatous lymphangitis
- •Congestive heart failure(NYHA class 3 or 4)
- •History of prosthesis on upper extremities
- •Use of drugs which may alter the fluid or electrolyte balance
结局指标
主要结局
CLUE score
时间窗: 1 month
Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) is a standardized clinical evaluation tool which was developed to evaluate the severity of the lymphedema, especially in the context of clinical trials. CLUE involves assessing obscuration of anatomical architecture (eg, bony prominences, tendons), deviation from normal anatomical contour, change of soft-tissue texture, and the presence of pitting or nonpitting edema. It consists of these four assessments conducted in three different parts or the upper extremity(arm, forearm and hand). CLUE scores have a range of 0 to 72, with greater numbers associated with more severe lymphedema. It was shown to be valid and reliable for the assessment of breast cancer related lymphedema by Spinelli et al.(1)
次要结局
- QuickDASH(1 Month)
- Extremity volume(1 Month)
- Lymphedema index(1 Month)
- Hand Grip Strength(1 Month)
研究者
Göksel Tanıgör M.D.
Researcher
Ege University