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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
R.J. Damstra, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier:
NCT01599039
First received: May 13, 2012
Last updated: February 11, 2014
Last verified: February 2014

May 13, 2012
February 11, 2014
May 2012
January 2014   (final data collection date for primary outcome measure)
Bio impedance spectometry [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01599039 on ClinicalTrials.gov Archive Site
  • body Mass Index (BMI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • quality of life measurement with the " LAST" meter [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
  • body Mass Index (BMI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • quality of life measurement with the " LAST" meter [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 indicate the need for addition support by healthcare workers to improve QoL
Not Provided
Not Provided
 
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Lymphedema
  • Breast Cancer Stage II
  • Early Disease Onset
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
January 2016
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01599039
NS3NL
No
R.J. Damstra, Nij Smellinghe Hosptial
Nij Smellinghe Hosptial
Not Provided
Not Provided
Nij Smellinghe Hosptial
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP