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

NCT01599039 | Completed

• 1 other identifier: NS3NL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Breast Cancer Stage II; Early Disease Onset

Keywords

early diagnostics; lymphedema; breast cancer; breast cancer related lymphedema; measuring methods; inverse water volumetry; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• body Mass Index (BMI)

  2 years

• quality of life measurement with the " LAST" meter

  2 years

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (1)

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Drachten, Provincie Friesland, 9202 NN, Netherlands

Location

Related Links

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

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert J Damstra, PhD

  Nij smellinghe hospital, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist MD PhD

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

NL (1)