Night-time Compression Systems for Breast Cancer Related Lymphedema
Breast Neoplasms, Lymphedema
About this trial
This is an interventional supportive care trial for Breast Neoplasms focused on measuring Breast cancer, Arm lymphedema, Compression therapy
Eligibility Criteria
Inclusion Criteria:
- Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
- Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
- Patients must have their own fitted compression garment for daytime maintenance.
- No past or current use of a night-time compression system for maintenance. Those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.
Exclusion Criteria:
- Clinical or radiological evidence of active disease, either local or metastatic.
- History of contralateral breast cancer and axillary surgery.
- Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
- Patients for whom compression is contraindicated.
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
- Unable to comply with the protocol, measurement and follow-up schedule.
Sites / Locations
- Holy Cross Centre
- Cross Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Immediate Night-time Compression
Delayed Group: Standard Care
Women randomized to the immediate night-time compression system group will be measured for a custom-made night-time compression system. Women in this group will be instructed to wear their night-time compression system garment for a minimum of 5 nights per week over the 12-week intervention period. A gradual increase in nights worn and wear-time of the garment will occur over the first two weeks. From weeks 3 to 12 of the study, the participants will be asked to wear the garment for 8 hours per night, for a minimum of five nights per week.
Women randomized to the delayed night-time compression system group will receive standard care for lymphedema maintenance. Each participant will be instructed to wear their day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week. Following the twelve-week delay period, women in this arm of the trial will be fitted for their respective night-time compression system garment and will follow the protocol outlined in the experimental arm of the trial.