Prospective Surveillance for Breast Cancer-Related Lymphedema

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Prevalence of chronic lymphedema — At 24 months post-surgery
  A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10

Trial sites (3)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Other trials for the same condition