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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
250
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.
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Prevalence of chronic lymphedema
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10
Time frame: At 24 months post-surgery
Time-to-treatment
INT group: The time (weeks) from surgery to first elevated L-DEX score which triggers immediate treatment along with time (weeks) to resolution of BCRL from diagnosis. For CON: time from surgery to BCRL diagnosis, time from diagnosis to BCRL treatment, and time from initiation to termination of treatment
Time frame: INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
Health-related quality of life
This will be measured by the EQ-5D questionnaire
Time frame: pre-treatment, 6, 12, 18 and 24 months post-surgery
Arm function
This will be measured by the QuickDASH questionnaire
Time frame: pre-treatment, 6, 12, 18 and 24 months post-surgery
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