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临床试验/NCT01599039
NCT01599039已完成不适用

Prospective Controlled Study Comparing the Effectiveness and Specificity of Inverse Water Volumetry Versus Bio-impedance Spectroscopy in the Assessment of Early Recognition of Breast Cancer Related Lymphoedema.

Nij Smellinghe Hosptial1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Bio impedance spectometry

研究概览

简要总结

The goal of the study is to investigate the use of bio-impedance spectroscopy in the assessment of breast cancer related lymphoedema in patients operated with lumpectomy or mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water volumetry. As a control group, patients with colon rectal cancer are used to compare volumetric and spectometric changes during follow-up.

详细描述

Current assessment of lymphoedema consists of measuring volume changes objectively by a tape measure or water displacement. Early recognition of pre-clinical changes of interstitial fluid congestion in a limb at risk concerning lymph transport capacity is crucial. Objective measurement of extracellular fluids with bio-impedance spectroscopy can detect these early signs of lymphoedema. Multi Frequency Bioelectrical Impedance Analysis is completely non-invasive, highly reproducible (Ward et al 1997), highly sensitive (Cornish et al 2001), highly specific (Cornish et al 2001) and can be repeated as frequently as desired. BIS demonstrated excellent inter- and intra-rater reliability. All measures are highly reliably in women with and without lymphoedema (Szerniec et al 2010). For women with lymphoedema BIS detected a difference in the ECF in limbs which were not reflected in a corresponding difference in limb volume. This finding suggests that BIS may be particularly useful in the early detection of lymphoedema, before there is any volume change (Szerniez et al 2010). The mean ratio of extra cellular water (ECW) to intracellular water (ICW) is 1,5:1 (Ward et al 2009). Cornish et al (2001) predicted the onset of the condition up to 10 months before the condition could be clinically diagnosed. This is considerable shorter than the mean delay time of 3,5 years reported by National Summit on Lymphoedema, Adelaide 2000. The only risk factor identified as contributing to an increased risk of developing secondary lymphoedema was an increasing BMI which is consistent with previous reports (Box et al 2002).

Early detection with BIS is supposed possible even before clinical signs of swelling are available.

In this study we want to study this hypothesis and as control-group patients treated for colorectal carcinoma.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gender: female
  • Patients operated with lumpectomy or mastectomy, Sentinel node, axillary lymphnode dissection and/or chemotherapy and/or radiotherapy.
  • Controls: operated for colon-rectal carcinoma with colectomy and adjuvant chemotherapy
  • Patients 18 years or older
  • No pre-existing clinical or volumetric signs of lymphoedema (CBO guideline: >10% difference with contra-lateral side

排除标准

  • Allergy against one of the used materials
  • Patients who have a pacemaker or other inbuilt stimulator
  • Women who are pregnant
  • Patients with renal failure or heart failure
  • Lymphoedema

结局指标

主要结局

Bio impedance spectometry

时间窗: 2 years

The participant's height (to 1 mm) and weight (to 0.1 kg) are measured prior to BIS assessment and entered into the device for processing. Whole arm impedance (wrist to axilla) will be determined according to the principle of equipotentials; a method shown to have greater precision than a 'paired electrode' approach. Participants were positioned in supine on a non-conductive bed with their arms by their side, pronated and slightly abducted. These result are compared with the gold standard (Inverse watter volumetry)

次要结局

  • body Mass Index (BMI)(2 years)
  • quality of life measurement with the " LAST" meter(2 years)

研究者

发起方
Nij Smellinghe Hosptial
申办方类型
Other
责任方
Principal Investigator
主要研究者

R.J. Damstra

Dermatologist MD PhD

Nij Smellinghe Hosptial

研究点 (1)

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