Clinical trial NCT01599039: Study the Usefulness of Bio-impedance Spectroscopy in the Early Assessment of Breast Cancer Related Lymphoedema
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Breast Cancer Stage II
Early Disease Onset
Keywords: early diagnostics
lymphedema
breast cancer
breast cancer related lymphedema
measuring methods
inverse water volumetry
prevention
Lead sponsor: Nij Smellinghe Hosptial
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There study population consists of breast cancer patients treated with either sentinel node biopsy either axillary dissection. As a control group we use colorectal cancer patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bio impedance spectometry
timeFrame: 2 years
Secondary outcomes:
measure: body Mass Index (BMI)
timeFrame: 2 years
measure: quality of life measurement with the " LAST" meter
timeFrame: 2 years
Other outcomes:
Locations:
city: Drachten
country: Netherlands
facility: Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
state: Friesland
Study officials:
affiliation: Nij smellinghe hospital, Netherlands
name: Robert J Damstra, PhD
role: PRINCIPAL_INVESTIGATOR
References: