Prospective Surveillance for Breast Cancer-Related Lymphedema

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Prospective surveillance

• Registration Number: NCT04522648
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Study Start: 2021-01-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (INT)	Prospective surveillance	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Arm function	pre-treatment, 6, 12, 18 and 24 months post-surgery	This will be measured by the QuickDASH questionnaire
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

Trial Locations

Locations (3)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark