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

Breast Cancer Clinical Trial

— DEARLY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210311
• Other study ID #: S60382
• Secondary ID: 2017-002306-12
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Sarah Thomis, MD
• Phone: 003216346948
• Email: sarah.thomis[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Diagnoses Disease
• Lymphedema
• Lymphedema of Upper Arm

Intervention

Device:
• compression
a compression stocking is worn, a garment compression class 2, flat knitted

Locations

Country	Name	City	State
Belgium	Vascular surgey Lymphovenous center	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphedema of arm and hand	defined as 5% volume increase compared to the contralateral side	up to 36 months
Primary	Deterioration of dermal backflow	measured by lymphofluoroscopy	up to 36 months
Secondary	Change of extracellular fluid change of extracellular fluid	measured by the BIS	up to 36 months
Secondary	Change of quality of life	measured by Mc Gill questionnaire	up to 36 months
Secondary	change of pitting status	measured by the pitting test at each visit	up to 36 months
Secondary	Change of water content	measured with moisture meter	up to 36 months
Secondary	change of skinfold tickness	measured by skinfold	up to 36 months
Secondary	relative change of arm volume difference	relative volume difference at assessment - relative volume difference at baseline	up to 36 months
Secondary	severity of disturbance of lymphatic transport	scoring dermal backflow in the 13 regions	up to 36 months
Secondary	problems in functioning related to development of lymphedema	measured by lymph ICF questionnaire	up to 36 months