Status:
COMPLETED
Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Cross Cancer Institute
Conditions:
Breast Cancer
Lymphedema
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 se...
Detailed Description
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of of treated breast cancer patients. An initial intensive rehabilitative treatment is usually prescribed to r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02187289
Start Date
October 1 2014
End Date
November 1 2019
Last Update
February 21 2021
Active Locations (3)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
Mount St. Joseph Hospital/Holy Family (MSJ/HF)
Vancouver, British Columbia, Canada, V5T 3N4