Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06324721

The Enigma of Subjective Lymphedema: Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling? The Role of Lymphatic and Sensory Processing Problems

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-01-29

230

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

U

Universiteit Antwerpen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Breast cancer related lymphedema (BCRL) affecting the arm and/or trunk is a serious complication after breast cancer treatment due to its long-lasting effects and impact on quality of life. Although the occurrence of objective BCRL has decreased with changes in breast cancer treatment, many patients still report a feeling of swelling without measurable BCRL, called subjective BCRL. Researchers aim to study the prevalence, transitions, and underlying mechanisms of subjective BCRL, focusing on lymphatic and sensory processing problems in breast cancer patients after surgery. This study involves breast cancer patients scheduled for surgery with either axillary lymph node dissection or sentinel node biopsy. Participants will undergo various clinical assessments to measure different types of BCRL at the arm and trunk/breast using volumetric measurements, bioimpedance, ultrasonography, lymphofluoroscopy, and sensory testing devices. These assessments will evaluate swelling, lymphatic function, and sensory problems at 1, 6, and 12 months after surgery to better understand the factors linked to subjective BCRL. Participants will be monitored over a year post-surgery through questionnaires and clinical tests assessing swelling, tissue changes, sensory loss, pain, muscle stiffness, and body perception. The study measures the presence and severity of both subjective and objective BCRL and related sensory impairments. This detailed follow-up includes physical exams, imaging, and sensory evaluations to track changes and identify contributing factors. The total participation duration is 12 months after surgery, with safety and outcome monitoring throughout this period.

CONDITIONS

Brief Title

Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (men and women) aged 18 years or older
  • Diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer
  • Scheduled for breast surgery (mastectomy or breast conserving surgery) with axillary lymph node dissection or sentinel node biopsy
  • Able to read, understand, and speak Dutch
  • Provide voluntary written informed consent
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Planned bilateral lymph node surgery
  • Edema of the arm from causes other than breast cancer
  • Allergy to iodine or Indocyanine Green (ICG)
  • Physically or mentally unable to participate for the entire study duration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

Duration - Up to 12 months post-surgery

Participants are observed to assess subjective and objective signs of lymphedema and related lymphatic and sensory processing problems after breast cancer surgery.

Visits occur up to 12 months after surgery to monitor symptoms and measurements

Trial Site Locations

Total: 1 location

1

University Hospitals of Leuven, center for lymphedema

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

N

Nele Devoogdt, Prof. Dr.

C

Ceren Gursen, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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Published Research Related To This Trial

Self-reported signs and symptoms of secondary upper limb lymphoedema related to breast cancer treatment: Systematic review.

Ceren Gursen, Elizabeth Sian Dylke, Niamh Moloney...

https://pubmed.ncbi.nlm.nih.gov/33733550

Correction to: Sensory signs and symptoms in women with self-reported breast cancer-related lymphedema: a case-control study.

An De Groef, Nele Devoogdt, Ceren Gursen...

https://pubmed.ncbi.nlm.nih.gov/34716888

Self-perceived, but not objective lymphoedema is associated with decreased long-term health-related quality of life after breast cancer surgery.

H Sackey, H Johansson, K Sandelin...

https://pubmed.ncbi.nlm.nih.gov/25659877

Patient-reported outcomes and objective assessments with arm measurement and bioimpedance analysis for lymphedema among breast cancer survivors.

Mitsuo Terada, Akiyo Yoshimura, Masataka Sawaki...

https://pubmed.ncbi.nlm.nih.gov/31535321

Prevalence of lymphedema in women with breast cancer 5 years after sentinel lymph node biopsy or axillary dissection: patient perceptions and precautionary behaviors.

Sarah A McLaughlin, Mary J Wright, Katherine T Morris...

https://pubmed.ncbi.nlm.nih.gov/18838708

LymphSens study: the enigma of subjective lymphoedema - how often and why do patients report lymphoedema after breast cancer treatment without an objective measurable swelling? The role of lymphatic and sensory processing problems: a protocol for a multicentre prospective longitudinal study.

Ceren Gursen, Mira Meeus, Kaat Verbeelen...

https://pubmed.ncbi.nlm.nih.gov/40484423