Status:
RECRUITING
Prospective Surveillance for Breast Cancer-Related Lymphedema
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aarhus University Hospital
Odense University Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphed...
Detailed Description
Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark. Procedure: All women booked for surgery for breast cancer at one of the study sites will be in...
Eligibility Criteria
Inclusion
- female;
- ≥18 years;
- surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed;
- can effectively communicate verbally in Danish;
Exclusion
- surgery for breast cancer with SLNB or \< 6 nodes removed;
- pre-existing lymphedema (primary or secondary);
- previous treatment for breast cancer;
- pace maker;
- conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04522648
Start Date
January 4 2021
End Date
December 1 2026
Last Update
August 18 2023
Active Locations (3)
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1
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
2
Herlev Hospital
Herlev, Denmark
3
Odense University Hospital
Odense, Denmark