METHODS
lymphoedema, Lymphoedema, breast cancer
LYMPHOEDEMA, LYMPHOEDEMA, METASTASIS, BREAST CANCER
As part of another prospective study (BEA)From these, participants developing RAVI between 4–9% within 9 months of surgery were recruited into this trial (PLACE) and subsequently randomised to compare intervention with a compression garment or standard management (Figure PLACE Trial Consort diagram. In the Flow diagram, the percentage Lymphoedema at each timepoint excludes the patients that dropped out, whereas in the main paper the percentage developing Lymphoedema is ITT so includes all patientsInclusion criteria: women aged 18–90 years with early breast cancer (no metastasis), who had undergone ANC.Exclusion criteria: women with inoperable breast cancer (T4 category or distant metastasis), previous axillary radiotherapy or clearance prior to consent, past history of breast/chest wall radiotherapy prior to entering the trial (radiotherapy to chest wall or breast as part of treatment after clearance was allowed).
Intervention: application of graduated compression garments (Sigvaris:20‐‐24 mmHg) to the affected arm for 12 months (applied by trained lymphoedema practioners to ensure good fit) together with written advice on elevation, exercises and self‐massage.Standard management: written advice on elevation, exercises and self‐massage.Ethical approval for both the BEA and PLACE trial was granted by the ethics review board (REC 10/H1003/35).All patients had a prestudy Body Mass Index (BMI) recorded and had BMI (weight) measurements repeated at each clinic visit to examine the potential relationship between high BMI and reduced compression sleeve efficiency.