Breast Cancer
Conditions
Keywords
lymphedema, Prospective surveillance
Brief 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.
Interventions
OTHERProspective 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.
Sponsors
Rigshospitalet, Denmark
Aarhus University Hospital
Odense University Hospital
Zealand University Hospital
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female; * ≥18 years; * surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed; * can effectively communicate verbally in Danish;
Exclusion criteria
* surgery for breast cancer with SLNB or \< 6 nodes removed; * pre-existing lymphedema (primary or secondary); * previous treatment for breast cancer; * pace maker; * conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-treatment | INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery | 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 |
| Health-related quality of life | pre-treatment, 6, 12, 18 and 24 months post-surgery | This will be measured by the EQ-5D questionnaire |
| Arm function | pre-treatment, 6, 12, 18 and 24 months post-surgery | This will be measured by the QuickDASH questionnaire |
Countries
Denmark
Outcome results
None listed