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Prospective Surveillance for Breast Cancer-Related Lymphedema
Sponsor: Rigshospitalet, Denmark
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 lymphedema.
Official title: Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2021-01-04
Completion Date
2026-12
Last Updated
2023-08-18
Healthy Volunteers
No
Conditions
Interventions
Prospective surveillance
A participant with an increase from pre-surgery in total arm volume of ≥6% by self-measurement, or symptoms of BCRL ≥2 NRS will receive an assessment by a lymphedema therapist. At this appointment, participants will receive a physical examination of the arm along with a BIS measurement. A participant is considered having subclinical BCRL if an increase in lymphedema index (L-DEX) ≥7 from pre-surgery measured by BIS is identified. A fitted compression garment and gauntlet is then provided, free of charge, for daily wear 10 hours/day for four weeks along with a recommendation to use the arm for daily activities and maintain regular physical activity. Following the four-week compression period, participants will be re-measured using BIS to evaluate response. Participants who do not respond to compression will receive CDT delivered by the lymphedema therapist.
Locations (3)
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark