Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Early Disease Onset | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- breast cancer patients with SN
- description
- 1\. Breast cancer patients with sentinel node biopsy (n=25)
- label
- breast cancer patients with AD
- description
- 2\. Breast cancer patients with axillary dissection (n=25)
- label
- colo-rectal patients
- description
- 3\. Colo-rectal patients as control group (n=25)
Primary outcomes (1)
- measure
- Bio impedance spectometry
- timeFrame
- 2 years
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available