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Completed

NCT Number: NCT03210311

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular surgey Lymphovenous center

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

compression

Device

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

Primary outcomes

  1. Incidence of lymphedema of arm and hand

    Time frame: up to 36 months

    defined as 5% volume increase compared to the contralateral side

  2. Deterioration of dermal backflow

    Time frame: up to 36 months

    measured by lymphofluoroscopy

Secondary outcomes

  1. Change of extracellular fluid change of extracellular fluid

    Time frame: up to 36 months

    measured by the BIS

  2. Change of quality of life

    Time frame: up to 36 months

    measured by Mc Gill questionnaire

  3. change of pitting status

    Time frame: up to 36 months

    measured by the pitting test at each visit

  4. Change of water content

    Time frame: up to 36 months

    measured with moisture meter

  5. change of skinfold tickness

    Time frame: up to 36 months

    measured by skinfold

  6. relative change of arm volume difference

    Time frame: up to 36 months

    relative volume difference at assessment - relative volume difference at baseline

  7. severity of disturbance of lymphatic transport

    Time frame: up to 36 months

    scoring dermal backflow in the 13 regions

  8. problems in functioning related to development of lymphedema

    Time frame: up to 36 months

    measured by lymph ICF questionnaire

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema

Acronym: DEARLY

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2017
Registry last updated
Jan 27, 2025

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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