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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03210311
Acronym
DEARLY
Enrollment
128
Registered
2017-07-06
Start date
2017-10-09
Completion date
2024-10-04
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema of Upper Arm, Breast Cancer, Diagnoses Disease

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.

Interventions

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of lymphedema of arm and handup to 36 monthsdefined as 5% volume increase compared to the contralateral side
Deterioration of dermal backflowup to 36 monthsmeasured by lymphofluoroscopy

Secondary

MeasureTime frameDescription
Change of water contentup to 36 monthsmeasured with moisture meter
Change of extracellular fluid change of extracellular fluidup to 36 monthsmeasured by the BIS
Change of quality of lifeup to 36 monthsmeasured by Mc Gill questionnaire
change of skinfold ticknessup to 36 monthsmeasured by skinfold
severity of disturbance of lymphatic transportup to 36 monthsscoring dermal backflow in the 13 regions
problems in functioning related to development of lymphedemaup to 36 monthsmeasured by lymph ICF questionnaire
relative change of arm volume differenceup to 36 monthsrelative volume difference at assessment - relative volume difference at baseline
change of pitting statusup to 36 monthsmeasured by the pitting test at each visit

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026