Spots Global Cancer Trial Database for Prospective Surveillance for Breast Cancer-Related Lymphedema

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Trial Identification

Brief Title: Prospective Surveillance for Breast Cancer-Related Lymphedema

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

Study ID: NCT04522648

Conditions

Breast Cancer

Interventions

Prospective surveillance

Study Description

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.