Lymphedema of Upper ArmDEARLYNCT03210311
Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema
A study testing compression in people with Lymphedema of Upper Arm and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphedema of Upper Arm, Breast Cancer, Diagnoses Disease
- What is being tested?
- compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Oct 2017to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vascular surgey Lymphovenous center
Leuven, Vlaams Brabant, 3000
About this study
Official title: Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development 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.
Read the 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
- Being tested
- compression
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compressionDevice
a compression stocking is worn, a garment compression class 2, flat knitted
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | * 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. |
| intervention group | Active comparator | * 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 Receives: Device: compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymphedema of arm and hand
defined as 5% volume increase compared to the contralateral side
Measured: up to 36 months
Deterioration of dermal backflow
measured by lymphofluoroscopy
Measured: up to 36 months
Secondary outcomes (8)
Change of extracellular fluid change of extracellular fluid
measured by the BIS
Measured: up to 36 months
Change of quality of life
measured by Mc Gill questionnaire
Measured: up to 36 months
change of pitting status
measured by the pitting test at each visit
Measured: up to 36 months
Change of water content
measured with moisture meter
Measured: up to 36 months
change of skinfold tickness
measured by skinfold
Measured: up to 36 months
relative change of arm volume difference
relative volume difference at assessment - relative volume difference at baseline
Measured: up to 36 months
severity of disturbance of lymphatic transport
scoring dermal backflow in the 13 regions
Measured: up to 36 months
problems in functioning related to development of lymphedema
measured by lymph ICF questionnaire
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start9 Oct 2017
- Primary completion1 Apr 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper ArmStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Sarah Thomis, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Sarah Thomis, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210311
- Sponsor's protocol ID
- S60382
- Other IDs
- 2017-002306-12, 2017
- Acronym
- DEARLY
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2017
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33277289
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Role of Pre-existing Factors, Early Diagnostic Options and Early Treatment in the Development of Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT03210311
- Acronym / sponsor ID
- DEARLY / S60382
- Conditions
- Lymphedema of Upper Arm, Breast Cancer, Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –* 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. |
| intervention group | Active comparator | Device: compression* 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compressiona compression stocking is worn, a garment compression class 2, flat knitted | Device | intervention group |
Primary outcome
Incidence of lymphedema of arm and hand
Time frame: up to 36 months
defined as 5% volume increase compared to the contralateral side
Deterioration of dermal backflow
Time frame: up to 36 months
measured by lymphofluoroscopy
8 secondary outcomes
Change of extracellular fluid change of extracellular fluid
Time frame: up to 36 months
Change of quality of life
Time frame: up to 36 months
change of pitting status
Time frame: up to 36 months
Change of water content
Time frame: up to 36 months
change of skinfold tickness
Time frame: up to 36 months
relative change of arm volume difference
Time frame: up to 36 months
severity of disturbance of lymphatic transport
Time frame: up to 36 months
problems in functioning related to development of lymphedema
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 33277289Thomis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Thomis, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression in people with Lymphedema of Upper Arm and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lymphedema of arm and hand (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.