Topic: National Cancer Research Network
Conditions
Interventions
Intervention:
Application of a graduated compression garment to the affected arm together with standard management for 12 months.
Control:
Standard man
Sponsors
University Hospital of South Manchester (UK)
Eligibility
Sex/Gender
Female
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. Consented to pre-surgical arm measurements by perometer and develop arm volume increases of 4 - 8.9% within 6 months after surgery 4. Willing to attend for follow-up visits per the trial schedule 5. Written informed consent to enter the PLACE trial
Exclusion criteria
Exclusion criteria: 1. Any patients with no 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 6. Past history of breast/chest wall radiotherapy 7. Previous axillary clearance, either unilateral or bilateral 8. Participation in another clinical trial of local therapy that may affect the results obtained in this study 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphoedema (greater than 10% arm volume increase compared to contralateral arm) at 2 and 5 years after axillary node clearance (assessed by perometer scanning). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (TOI and FACT B+4) 2. Costs of individual strategies (EQ5D utility measures) 3. Incidence of infection/lymphangitis at 2 years after surgery 4. Arm movement | — |
Countries
United Kingdom
Outcome results
None listed