Lymphoedema in patients with breast cancer Cancer Breast cancer
Conditions
Interventions
Arm volume will be measured at baseline, 1, 3, and 6 monthly thereafter to 2 years, followed by annual measurements up to 5 years using perometer arm scanning and bioimpedance. Quality of Life questio
Sponsors
University Hospital of South Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphoedema (greater than 10% arm volume increase compared to contralateral arm) at 2 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of multi-frequency bioimpedance with perometer measurement 2. Prediction of lymphoedema by multi-frequency bioimpedance at 24 months 3. Quality of life in each group 4. Multivariate model assessment of factors predicting lymphoedema at 24 months 5. Lymphoedema symptoms related to changes in arm volume and bioimpedance readings | — |
Countries
United Kingdom
Outcome results
None listed