Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.

Sex

Female

Inclusion Criteria:

* Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
* Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
* In or entering upon the maintenance phase of lymphedema treatment.
* Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
* No current use of night-time compression (one month wash-out period before trial entry)

Exclusion Criteria:

* Clinical or radiological evidence of active disease, either local or metastatic
* History or clinical diagnosis of bilateral arm lymphedema
* Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
* Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
* Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period

• DERIVEDMcNeely ML, Dolgoy ND, Rafn BS, Ghosh S, Ospina PA, Al Onazi MM, Radke L, Shular M, Kuusk U, Webster M, Campbell KL, Mackey JR. Nighttime compression supports improved self-management of breast cancer-related lymphedema: A multicenter randomized controlled trial. Cancer. 2022 Feb 1;128(3):587-596. doi: 10.1002/cncr.33943. Epub 2021 Oct 6. PMID 34614195
• DERIVEDMcNeely ML, Campbell KL, Webster M, Kuusk U, Tracey K, Mackey J. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial. BMC Cancer. 2016 Aug 4;16:601. doi: 10.1186/s12885-016-2648-8. PMID 27491361