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    Clinical Trial Results:
    Determining the role of pre-existing factors, early diagnostic options and early treatment in the development of breast cancer related lymphedema.

    Summary
    EudraCT number
    		 2017-002306-12
    Trial protocol
    		 BE  
    Global end of trial date
    03 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2025
    First version publication date
    25 Jan 2025
    Other versions
    Summary report(s)
    		 final results

    Trial information

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    Trial identification
    Sponsor protocol code
    S60382
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03210311
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Secretariaat vaatheelkunde, University Hospitals Leuven, 0032 16346850, sarah.thomis@uzleuven.be
    Scientific contact
    Secretariaat vaatheelkunde, University Hospitals Leuven, 0032 0498296629, sarah.thomis@uzleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective entails detecting early development of lymphedema and establishing a decrease in the incidence of lymphedema and/or improvement or stabilization of the lymphofluoroscopic image when treatment is started early.
    Protection of trial subjects
    In accordance with the Belgian Law relating to experiments on human persons dated May 7, 2004, Sponsor shall assume, even without fault, the responsibility of any damages incurred by a Study Patient and linked directly or indirectly to the participation to the Study, and shall provide compensation therefore through its insurance.”
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 128
    Worldwide total number of subjects
    128
    EEA total number of subjects
    128
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    92
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients are recruited at the preoperative consultation of the Multidisciplinary Breast Clinic. Leaflet will be handed out and the trial will be explained.

    Pre-assignment
    Screening details
    		 Patients scheduled for breast surgery and either unilateral axillary lymph node dissection (ALND) or sentinel node biopsy (SNB) in the Multidisciplinary Breast Clinic in the University Hospitals Leuven (N=128) will be screened for participation in the study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 preventive treatment group
    Arm description
    		 compression garment was added to the standard of care treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Indocyanine Green pulsion 25 mg
    Investigational medicinal product code
    3588 IE 1 F 0
    Other name
    Verdeye
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Injection , Intralymphatic use
    Dosage and administration details
    0.2ml (of 25 mg ICG diluted in 25ml NaCl) in two injection sites of the hand

    Arm title
    		 standard of care group
    Arm description
    		 patients received standard of care treatment consisting out of exercises, skin care
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: the assessor was blinded, she dind't knew in which group the patient was allocated
    Number of subjects in period 1 [2]
    		preventive treatment group standard of care group
    Started
    19
    20
    Completed
    13
    13
    Not completed
    6
    7
         Lost to follow-up
    6
    7
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: the total number of patients in the study was 128, but only 39 patients were randomized and analyzed

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    preventive treatment group
    Reporting group description
    		 compression garment was added to the standard of care treatment

    Reporting group title
    standard of care group
    Reporting group description
    		 patients received standard of care treatment consisting out of exercises, skin care

    Reporting group values
    		 preventive treatment group standard of care group Total
    Number of subjects
    		 19 20 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 12 17 29
        From 65-84 years
    		 7 3 10
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 19 20 39
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Randomized patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    - Patients in the treatment group will have a: o Increase of the incidence of lymphedema of arm and hand (defined as 5% volume increase compared to the contralateral side) o Improvement or stabilization of lymphatic transport visualized and measured by ICG fluoroscopy - Patients with more aggressive breast-cancer treatment will have a higher chance of developing lymphedema. - Early detection of lymphedema is possible by visualizing an abnormal pattern of ICG lymphofluoroscopy and/or by measuring lower velocity times of the lymph transport. - Early detection of lymphedema is possible by measuring o Change of volume measurements of the hand/arm o Change of extracellular fluid in the arm

    Subject analysis sets values
    		 Randomized patients
    Number of subjects
    39
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    27
        From 65-84 years
    10
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    37
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    preventive treatment group
    Reporting group description
    		 compression garment was added to the standard of care treatment

    Reporting group title
    standard of care group
    Reporting group description
    		 patients received standard of care treatment consisting out of exercises, skin care

    Subject analysis set title
    Randomized patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    - Patients in the treatment group will have a: o Increase of the incidence of lymphedema of arm and hand (defined as 5% volume increase compared to the contralateral side) o Improvement or stabilization of lymphatic transport visualized and measured by ICG fluoroscopy - Patients with more aggressive breast-cancer treatment will have a higher chance of developing lymphedema. - Early detection of lymphedema is possible by visualizing an abnormal pattern of ICG lymphofluoroscopy and/or by measuring lower velocity times of the lymph transport. - Early detection of lymphedema is possible by measuring o Change of volume measurements of the hand/arm o Change of extracellular fluid in the arm

    Primary: Presence of clinical lymphedema

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    End point title
    		 Presence of clinical lymphedema
    End point description
    presence of lymphedema measured with circumference measurements dan defined as > 5% volume difference
    End point type
    Primary
    End point timeframe
    12M
    End point values
    		 preventive treatment group standard of care group Randomized patients
    Number of subjects analysed
    13
    13
    26
    Units: 2
    6
    4
    10
    Statistical analysis title
    		 logistic regression analysis
    Comparison groups
    preventive treatment group v standard of care group
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.508
         upper limit
    		 8.125

    Primary: evolution of dermal backflow

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    End point title
    		 evolution of dermal backflow
    End point description
    evolution of dermal backflow worsening = 1 stable or better = 0
    End point type
    Primary
    End point timeframe
    12M
    End point values
    		 preventive treatment group standard of care group Randomized patients
    Number of subjects analysed
    13
    13
    26
    Units: 2
    6
    7
    13
    Statistical analysis title
    		 logistic regression analysis
    Comparison groups
    preventive treatment group v standard of care group
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 6.493

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The sponsor shall ensure that all relevant information about suspected unexpected serious adverse reactions that are fatal or life-threatening is recorded and reported as soon as possible to the minister, to the competent authorities in all the Member Sta
    Adverse event reporting additional description
    8.2.1 Definitions in Law of May 7, 2004 concerning experiments on the human person Adverse reaction (AR): all untoward and unintended responses to an investigational medicinal product or to an experiment and, when an investigational product is concerned, related to any dose administered; Adverse event (AE): any untoward medical occurrence in a
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no AE reportes
    Dictionary version
    1
    Reporting groups
    Reporting group title
    standard of care
    Reporting group description
    		 -

    Reporting group title
    preventive treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 standard of care preventive treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 standard of care preventive treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: there were no adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39253841
    http://www.ncbi.nlm.nih.gov/pubmed/36980660
    http://www.ncbi.nlm.nih.gov/pubmed/33277289
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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