Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema

NCT03210311 | Completed

• 2 other identifiers: S603822017-002306-12
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and treatment is very important to alter the normal progression of this disease. A threshold (\>= 3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is diagnosed late, options for treatment are diminished as fibrous tissue is formed. Preoperative investigation with near-infrared fluorescence lymphography can show an abnormality. Even if a linear transport is visualized, velocity of the transport can be diminished or a different pathway than normal can be visualized. Such an extensive evaluation has not been performed yet. This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be altered if treatment is started in the subclinical phase.

Conditions

Lymphedema of Upper Arm; Breast Cancer; Diagnoses Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of lymphedema of arm and hand

  defined as 5% volume increase compared to the contralateral side

  up to 36 months

• Deterioration of dermal backflow

  measured by lymphofluoroscopy

  up to 36 months

Secondary Outcomes (8)

• Change of extracellular fluid change of extracellular fluid

  up to 36 months

• Change of quality of life

  up to 36 months

• change of pitting status

  up to 36 months

• Change of water content

  up to 36 months

• change of skinfold tickness

  up to 36 months

Study Arms (2)

control group

NO INTERVENTION

* Receive information: the patient receive a leaflet with information about the lymphatic system and lymphedema, clinical evaluation and conservative treatment of lymphedema * Perform skin care * Perform twice a day upper limb exercises at home. They are advised to use the arm as normal as possible.

intervention group

ACTIVE COMPARATOR

* Receive information: the patient receive a leaflet with information about the lymphatic system and lymphedema, clinical evaluation and conservative treatment of lymphedema * Perform skin care * Perform upper limb exercises at home twice a day. They are advised to use the arm as normal as possible * Wear a compression sleeve

Device: compression

Interventions

compression DEVICE

a compression stocking is worn, a garment compression class 2, flat knitted

intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18y (since the investigation using ICG is not dangerous for pregnant women, women with child bearing age are included)
• Women/ men with breast cancer and scheduled for unilateral axillary lymph node dissection (ALND) or sentinel node biopsy (SNB)
• Oral and written approval of informed consent
• Dutch speaking

You may not qualify if:

• Oedema of the upper limb from other causes
• Cannot participate during the entire study period
• Mentally or physically unable to participate in the study
• Contra-indication for the use of ICG: allergy to iodine, hyperthyroidism
• Metastatic disease

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Vascular surgey Lymphovenous center

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• Thomis S, Devoogdt N, Bechter-Hugl B, Nevelsteen I, Neven P, Fourneau I. Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial. BMJ Open. 2020 Dec 4;10(12):e042018. doi: 10.1136/bmjopen-2020-042018.

  PMID: 33277289 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Thomis, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 6, 2017
• Study Start: October 9, 2017
• Primary Completion: April 1, 2024
• Study Completion: October 4, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)