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
  Purpose

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
Lymphedema
Breast Cancer Stage II
Early Disease Onset

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Nij Smellinghe Hosptial:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 75
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599039

Locations
Netherlands
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Friesland, Netherlands, 9202 NN
Sponsors and Collaborators
Nij Smellinghe Hosptial
  More Information

Additional Information:
No publications provided

Responsible Party: R.J. Damstra, Dermatologist MD PhD, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier: NCT01599039     History of Changes
Other Study ID Numbers: NS3NL
Study First Received: May 13, 2012
Last Updated: February 11, 2014
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Nij Smellinghe Hosptial:
early diagnostics
lymphedema
breast cancer
breast cancer related lymphedema
measuring methods
inverse water volumetry
prevention

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014