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临床试验/NCT03992508
NCT03992508已完成不适用

The Effects of Compression and Massage Therapies in the Treatment of Breast Cancer-related Lymphoedema

Aydin Adnan Menderes University0 个研究点目标入组 76 人开始时间: 2012年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
主要终点
Change of excess arm volume from baseline

研究概览

简要总结

To evaluate the role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema.

详细描述

Patients with unilateral arm lymphoedema were enrolled and all were hospitalized. The participating patients were randomly divided into two groups.

Demographic features of the patients including age, body mass index [BMI = weight (kg) / height2 (m2)], duration of lymphoedema (months) and number of axillary lymph nodes removed were all recorded. The volume (V) of every part of the limb was calculated by the truncated cone formula according to circumferential measurements and the total volume is estimated by the sum of the increments. Circumference measurements were taken at 4-centimetre intervals along the arm from the level of the ulnar styloid to the shoulder with a flexible non-stretch tape measure. The volume between every two circumferential measurement levels was calculated using the following formula:

Volume = h (C2 + Cc + c2) / 12π In this formula, C is the first circumferential measurement (circumference of the top of the cone), c is the second circumferential measurement (circumference of the base of the cone) and h is the height from measurement C to c. Both the affected and non-affected limbs were evaluated by the same examiner. An Excel-based software program was used to convert these values into limb volumes in mL.

The severity of lymphoedema was characterized by the percentage excess volume (PEV) PEV = [(VLE - VH) / VH] x 100 where VLE denotes the volume of the lymphoedema arm and VH is that of the healthy arm. PEV is the preferred quantity for defining the severity of lymphoedema than the absolute difference volume. Also, this method minimizes the effects of BMI on the volume estimates. The efficacy of complex decongestive therapy, the response to the therapeutic intervention, was also quantified by the percentage reduction of excess volume (PREV) PREV = [(pre-treatment VLE - post-treatment VLE) / excess volume)] x 100. Other assessments of clinical origin were also conducted on the patients by physical therapists who were blind to the applied treatment and the timing of the data collection point. Pitting oedema was evaluated at multiple points on the forearm by pressing the thumb on the region to be investigated for a minute as hard as possible, as such test is considered as an indicator of the presence of excess free fluid accumulated in the superficial interstitial tissue spaces. The Stemmer's sign was performed as an inability to pinch the fold of skin at the base of the finger.

Clinical symptoms of pain (during activity, resting and night), heaviness and tightness in the affected arm were evaluated with Visual Analog Scale (VAS) with a 0-10 numerical rating scale. The patients' functional situation was assessed by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome questionnaire which is a self-reported assessment tool for the measurement of physical function and symptoms in individuals with a musculoskeletal disorder of the upper limb. This instrument was also reported as a convenient, reliable, and valid patient-reported outcome measure to assess upper extremity disability in patients with breast cancer. The scores indicated the level of disability and severity, ranging from 0 (no disability) to 100 (most severe disability).

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • breast cancer-related lymphoedema due to unilateral breast cancer
  • more than 2 cm difference at the circumference measurements or >10% difference in volume between the two arms
  • completed chemotherapy and radiotherapy

排除标准

  • bilateral breast cancer
  • primer lymphoedema
  • undergone complex decongestive therapy or other interventions for lymphoedema within 12 months
  • truncal and/or breast oedema
  • continuing chemotherapy and/or radiotherapy
  • active infection
  • current metastases
  • heart failure with arterial and/or venous occlusion
  • elephantiasis
  • impaired cognitive status
  • received physiotherapy within last six months
  • cervical or cranial originated upper extremity problems
  • using any medications that affect the body fluid and electrolyte balance

结局指标

主要结局

Change of excess arm volume from baseline

时间窗: a month

The volume of every part of the limb was calculated in liter by the truncated cone formula according to circumferential measurements.

次要结局

  • Change of arm pain, heaviness and tightness from baseline(a month)
  • Change of disability from baseline(a month)
  • Change of grip strength from baseline(a month)
  • Change of depression from baseline(a month)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Engin Tastaban

Assistant Professor

Aydin Adnan Menderes University

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