Trial Information

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.

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.