Prospective Surveillance for Breast Cancer-Related Lymphedema

NCT04522648 | Active Not Recruiting

• 1 other identifier: PROTECT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

lymphedema; Prospective surveillance

Outcome Measures

Primary Outcomes (1)

• Prevalence of chronic lymphedema

  A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10

  At 24 months post-surgery

Secondary Outcomes (3)

• Time-to-treatment

  INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery

• Health-related quality of life

  pre-treatment, 6, 12, 18 and 24 months post-surgery

• Arm function

  pre-treatment, 6, 12, 18 and 24 months post-surgery

Study Arms (2)

Intervention (INT)

EXPERIMENTAL

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.

Other: Prospective surveillance

Control (CON)

NO INTERVENTION

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.

Interventions

Prospective surveillance OTHER

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.

Intervention (INT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female;
• ≥18 years;
• surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed;
• can effectively communicate verbally in Danish;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Herlev Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (3)

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: January 4, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)