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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01599039
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
R.J. Damstra, Nij Smellinghe Hosptial

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.

Condition or disease
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
Actual Enrollment : 80 participants
Time Perspective: Prospective
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 Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Bio impedance spectometry [ Time Frame: 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)

Secondary Outcome Measures :
  1. body Mass Index (BMI) [ Time Frame: 2 years ]
    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. quality of life measurement with the " LAST" meter [ Time Frame: 2 years ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01599039

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Friesland, Netherlands, 9202 NN
Sponsors and Collaborators
Nij Smellinghe Hosptial
Principal Investigator: Robert J Damstra, PhD Nij smellinghe hospital, Netherlands

Additional Information:
Responsible Party: R.J. Damstra, Dermatologist MD PhD, Nij Smellinghe Hosptial Identifier: NCT01599039     History of Changes
Other Study ID Numbers: NS3NL
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by R.J. Damstra, Nij Smellinghe Hosptial:
early diagnostics
breast cancer
breast cancer related lymphedema
measuring methods
inverse water volumetry

Additional relevant MeSH terms:
Breast Neoplasms
Breast Cancer Lymphedema
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes