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

Primary Purpose

Lymphedema of Upper Arm, Breast Cancer, Diagnoses Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
compression
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Upper Arm

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vascular surgey Lymphovenous centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

intervention group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Incidence of lymphedema of arm and hand
defined as 5% volume increase compared to the contralateral side
Deterioration of dermal backflow
measured by lymphofluoroscopy

Secondary Outcome Measures

Change of extracellular fluid change of extracellular fluid
measured by the BIS
Change of quality of life
measured by Mc Gill questionnaire
change of pitting status
measured by the pitting test at each visit
Change of water content
measured with moisture meter
change of skinfold tickness
measured by skinfold
relative change of arm volume difference
relative volume difference at assessment - relative volume difference at baseline
severity of disturbance of lymphatic transport
scoring dermal backflow in the 13 regions
problems in functioning related to development of lymphedema
measured by lymph ICF questionnaire

Full Information

First Posted
June 29, 2017
Last Updated
October 26, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03210311
Brief Title
Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema
Acronym
DEARLY
Official Title
Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Arm, Breast Cancer, Diagnoses Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
compression
Intervention Description
a compression stocking is worn, a garment compression class 2, flat knitted
Primary Outcome Measure Information:
Title
Incidence of lymphedema of arm and hand
Description
defined as 5% volume increase compared to the contralateral side
Time Frame
up to 36 months
Title
Deterioration of dermal backflow
Description
measured by lymphofluoroscopy
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Change of extracellular fluid change of extracellular fluid
Description
measured by the BIS
Time Frame
up to 36 months
Title
Change of quality of life
Description
measured by Mc Gill questionnaire
Time Frame
up to 36 months
Title
change of pitting status
Description
measured by the pitting test at each visit
Time Frame
up to 36 months
Title
Change of water content
Description
measured with moisture meter
Time Frame
up to 36 months
Title
change of skinfold tickness
Description
measured by skinfold
Time Frame
up to 36 months
Title
relative change of arm volume difference
Description
relative volume difference at assessment - relative volume difference at baseline
Time Frame
up to 36 months
Title
severity of disturbance of lymphatic transport
Description
scoring dermal backflow in the 13 regions
Time Frame
up to 36 months
Title
problems in functioning related to development of lymphedema
Description
measured by lymph ICF questionnaire
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Thomis, MD
Phone
003216346948
Ext
0032498296629
Email
sarah.thomis@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
wendy leus
Phone
003216341759
Ext
0032498296629
Email
wendy.leus@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Thomis, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular surgey Lymphovenous center
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Thomis, MD
Phone
003216346948
Email
sarah.thomis@uzleuven.be
First Name & Middle Initial & Last Name & Degree
wendy Leus
Phone
003216341759
Email
wendy.leus@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33277289
Citation
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.
Results Reference
derived

Learn more about this trial

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

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