Prospective Surveillance for Breast Cancer-Related Lymphedema (PROTECT)
Breast Cancer
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring lymphedema, Prospective surveillance
Eligibility Criteria
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).
Sites / Locations
- Copenhagen University Hospital RigshospitaletRecruiting
- Herlev HospitalRecruiting
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention (INT)
Control (CON)
INT participants will be asked to perform self-measurements of arm circumference at five points along the arm at home every three months. Additional measurements can be performed if the participants experience signs of BCRL. Participants will report the self-measurements in cm and mm in an online questionnaire, or over the phone to a physiotherapist navigator, along with reporting sign and symptoms of BCRL.
The CON group will follow the usual post-operative care. CON participants will be prompted every 6 months by an online questionnaire to report if they have been diagnosed with BCRL and if so, month of initiation of treatment.