V.S. Paramanandam1,2, E. Dylke1, A. Daptardar2, M. Kamat2, N. Nair3, S. Joshi3, M.-J. Lee1, S. Kilbreath1
1The University of Sydney, Faculty of Medicine and Health, Sydney, Australia, 2Tata Memorial Hospital, Physiotherapy Department, Mumbai, India, 3Tata Memorial Hospital, Department of Surgical Oncology, Mumbai, India
Background: Breast cancer-related lymphoedema (BCRL) is a common, long-term complication following treatment for breast cancer with one in five women developing it following axillary lymph node dissection (ALND). Preliminary findings suggest that a compression sleeve may be useful its prevention. However, adequately powered, randomised controlled trials (RCTs) are needed to study the pre-emptive use of compression sleeve in BCRL.
Purpose: As arm swelling in the first year is predictive of long-term lymphoedema, we evaluated the efficacy of a compression sleeve in the prevention of arm swelling in women at high-risk for BCRL compared to the usual care in the first year following surgery for breast cancer.
Methods: This single-blind (Assessor), parallel-group (1:1 ratio) RCT was conducted from 2018 to 2020 in Mumbai, India. Three hundred and six women who had undergone ALND as part of their breast cancer surgery were stratified on body mass index and neo-adjuvant taxane-based chemotherapy, then randomly assigned to either the compression sleeve group or to the usual care group. In addition to the usual postoperative care, participants in the compression group were provided with two compression garments (SIGVARIS Advance Arm sleeve, 20-25 mmHg) to wear from the first postoperative day until three months after completion of adjuvant treatments. Women were instructed to wear the garment during waking hours. Arm swelling was confirmed if the interarm impedance ratio increased by more than two standard deviations from their pre-surgery baseline ratio. Participants with at least one follow-up visit postoperatively were included in the survival curve analysis. Participants who were lost to follow up or died during the intervention period were censored after the last known follow-up, and all cases were right censored at 56 weeks.
Results: Arm swelling occurred significantly less frequently in the compression group (38%) than the usual care group (55%) (Log-rank test; P = 0.004). In addition, the arm swelling free survival time was significantly longer for the compression group than the usual care group (n = 301; Hazard ratio = 0.62 [95% CI: 0.44 to 0.86]; p = 0.005). The median swelling free survival time for compression group was longer (>56 weeks) than the usual care group (42 weeks). Apart from the group allocation, the age of the participants significantly influenced the arm swelling free survival time (n = 301; Hazard ratio = 1.02 [95%CI: 1 to 1.03]; p<0.028).
Conclusion(s): Pre-emptive use of a compression sleeve compared to the usual care reduced the occurrence of arm swelling in women at high-risk for BCRL in the first year after surgery for breast cancer.
Implications: Women undergoing ALND as part of their breast cancer surgery may benefit from the pre-emptive use of compression sleeve to prevent arm swelling in the first year, which is an important factor for the development of chronic BCRL.
Funding, acknowledgements: Mr Vincent Singh Paramanandam was supported by the University of Sydney International strategic scholarship and grant from Sigvaris AG (Switzerland)
Keywords: Breast-cancer related lymphoedema, compression sleeve, prevention
Topic: Oncology, HIV & palliative care
Did this work require ethics approval? Yes
Institution: Tata Memorial Hospital, India
Committee: Institutional Ethics Commitee-1
Ethics number: IEC/1217/1964/001
All authors, affiliations and abstracts have been published as submitted.
