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RECRUITING
NCT04522648
NA

Prospective Surveillance for Breast Cancer-Related Lymphedema

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

OTHER

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