Prospective Surveillance for Breast Cancer-Related Lymphedema

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

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.

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).