Prospective Surveillance for Breast Cancer-Related Lymphedema

Breast Cancer Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522648
• Other study ID #: PROTECT
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Rigshospitalet, Denmark
• Contact: Bolette S Rafn, PhD
• Phone: +45 22913873
• Email: bolette.skjoedt.rafn[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Prospective surveillance
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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital, Herlev Hospital, Odense University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time-to-treatment	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	INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
Secondary	Health-related quality of life	This will be measured by the EQ-5D questionnaire	pre-treatment, 6, 12, 18 and 24 months post-surgery
Secondary	Arm function	This will be measured by the QuickDASH questionnaire	pre-treatment, 6, 12, 18 and 24 months post-surgery