Multifrequency bioimpedance in the early detection of lymphoedema

Not Applicable

Completed

• Conditions: ymphoedema in patients with breast cancer; Cancer; Breast cancer

• Registration Number: ISRCTN48880939
• Lead Sponsor: niversity Hospital of South Manchester (UK)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25850535

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-04
• Study Completion: 2015-07-29
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Women aged 18 - 90 years
2. Early breast cancer (no evidence of metastatic disease by local screening procedures) scheduled to undergo axillary node clearance
3. Willing to consent to pre-surgical arm measurements by perometry and beauvericin (BEA)
4. Agreeable to follow-up for up to 5 years

Exclusion Criteria

1. Any patients unwilling to consent to pre-surgical baseline measurements
2. Known distant metastasis
3. Inoperable breast cancer (T4 category or distant metastasis)
4. Node negative not undergoing axillary clearance
5. Previous axillary radiotherapy or clearance
6. Past history of breast / chest wall radiotherapy
7. Previous axillary clearance; either uni- or bi-lateral
8. Pregnancy
9. External pacemaker / defibrillator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Incidence of lymphoedema (greater than 10% arm volume increase compared to contralateral arm) at 2 and 5 years<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Comparison of multi-frequency bioimpedance with perometer measurement<br> 2. Prediction of lymphoedema by multi-frequency bioimpedance at 24 months<br> 3. Quality of life in each group<br> 4. Multivariate model assessment of factors predicting lymphoedema at 24 months<br> 5. Lymphoedema symptoms related to changes in arm volume and bioimpedance readings<br>