Study the Usefulness of Bio-impedance Spectroscopy in the Early Assessment of Breast Cancer Related Lymphoedema

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.

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema; Breast Cancer Stage II; Early Disease Onset

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Drachten, Friesland, Netherlands, 9202 NN
      • Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
breast cancer patients with SN; 1. Breast cancer patients with sentinel node biopsy (n=25)
breast cancer patients with AD; 2. Breast cancer patients with axillary dissection (n=25)
colo-rectal patients; 3. Colo-rectal patients as control group (n=25)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bio impedance spectometry	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)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body Mass Index (BMI)	The body mass index (or BMI) is a measure which shows whether people have the right weight for their height. The World Health Organisation (WHO), governments and health workers use it. It is also called the Quetelet Index.	2 years
quality of life measurement with the " LAST" meter	The "lastmeter" is a validated tool in the Dutch language to score the psycho-social and physical situation of a cancer patient. The scale is between 0-10 and includes several questions. This indicates the need for addition support by healthcare workers to improve QoL	2 years

Collaborators and Investigators

• Sponsor: Nij Smellinghe Hosptial
• Investigators: Principal Investigator: Robert J Damstra, PhD, Nij smellinghe hospital, Netherlands

Publications and helpful links

Helpful Links

• The foundation related to the expert centre organizing research
• General website form the Nij Smellinghe hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 13, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: breast cancer; prevention; lymphedema; early diagnostics; breast cancer related lymphedema; measuring methods; inverse water volumetry
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: NS3NL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No