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NCT Number: NCT04522648

Prospective Surveillance for Breast Cancer-Related Lymphedema

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of chronic lymphedema

    Time frame: At 24 months post-surgery

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

Secondary outcomes

  1. Time-to-treatment

    Time frame: 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

  2. Health-related quality of life

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

    This will be measured by the EQ-5D questionnaire

  3. Arm function

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

    This will be measured by the QuickDASH questionnaire

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Herlev Hospital
  • Odense University Hospital
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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