Prospective Surveillance for Breast Cancer-Related Lymphedema

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

January 4, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
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.

Trial Locations (3)

2100

RECRUITING

Copenhagen University Hospital Rigshospitalet, Copenhagen

Unknown

RECRUITING

Herlev Hospital, Herlev

RECRUITING

Odense University Hospital, Odense

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

Zealand University Hospital

OTHER

collaborator

Herlev Hospital

OTHER

lead

Rigshospitalet, Denmark

OTHER