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

NCT ID: NCT01599039

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Lymphedema; Breast Cancer Stage II; Early Disease Onset

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

breast cancer patients with SN

1\. Breast cancer patients with sentinel node biopsy (n=25)

No interventions assigned to this group

breast cancer patients with AD

2\. Breast cancer patients with axillary dissection (n=25)

No interventions assigned to this group

colo-rectal patients

3\. Colo-rectal patients as control group (n=25)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nij Smellinghe Hosptial

OTHER

Sponsor Role: lead

Responsible Party

R.J. Damstra

Dermatologist MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J Damstra, PhD

Role: PRINCIPAL_INVESTIGATOR

Nij smellinghe hospital, Netherlands

Locations

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Drachten, Provincie Friesland, Netherlands

Countries

Netherlands

Related Links

http://www.slcn.nl

The foundation related to the expert centre organizing research

http://www.nijsmellinghe.nl

General website form the Nij Smellinghe hospital

Other Identifiers

NS3NL

Identifier Type: -

Identifier Source: org_study_id