NCT04522648

Prospective Surveillance for Breast Cancer-Related Lymphedema

Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had \>6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-08-21
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Denmark