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

NCT ID: NCT03210311

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2024-10-04

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.

Detailed Description

Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Estimates of incidence rates have varied over time, especially since the progression to less invasive techniques as sentinel node procedures and radiotherapy. According to a review article of DiSipio the incidence of arm lymphedema was about four times higher in women who had an axillary lymph node dissection (18 studies; 19.9%, 13.5-28.2) than in those who had sentinel lymph node biopsy (18 studies; 5.6%, 6.1-7.9). Several other risk factors are already suggested as having a negative impact on the development of lymphedema such as BMI and chemotherapy. A comprehensive overview of all treatment related risk factors and patient related risk factors, including demographics, has not been reported yet.

Lymphedema is identified with upper limb volume measurements eg circumference measurements, water displacement and perometer. Bioimpedance spectroscopy can also be used to assess the extracellular fluid. A 10% limb volume change has been reported as the most accurate threshold to diagnose lymphedema. However, with this definition an underestimation of the incidence rate of lymphoedema is made. Therefore, recently a threshold of 5% limb volume change is proposed.

A study by Rockson et al suggested that in almost 75 % of the cases, lymphoedema is established in the first year after breast cancer treatment. But up to two years after surgery, there still is a possibility to develop lymphoedema.

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.

During near-infrared fluorescence lymphography (lymphofluoroscopy), a fluorescent substance is injected subcutaneously in the hand and the transport of lymph is visualized from the hand up to the axilla. A normal transport is defined as a linear image and an abnormal transport as a dermal backflow image. The dermal backflow image is divided in three different classifications according to the severity.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

• 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

• 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

Group Type: ACTIVE_COMPARATOR

compression

Intervention Type: DEVICE

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

Interventions

compression

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

dr. Sarah Thomis

Vascular Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Thomis, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Vascular surgey Lymphovenous center

Leuven, Vlaams Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33277289 (View on PubMed)

Other Identifiers

2017-002306-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S60382

Identifier Type: -

Identifier Source: org_study_id