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    Clinical Trial Results:
    Prevention of breast cancer-related lymphedema with tacrolimus

    Summary
    EudraCT number
    		 2018-003416-50
    Trial protocol
    		 DK  
    Global end of trial date
    22 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2023
    First version publication date
    21 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2018-BCRL-TACRO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04390685
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense university Hospital
    Sponsor organisation address
    J.B. Winsløws vej 4, Odense, Denmark, 5000
    Public contact
    Dept. of Plastic Surgery, Odense University Hospital, 0045 65412436 , jens.sorensen@rsyd.dk
    Scientific contact
    Dept. of Plastic Surgery, Odense University Hospital, 0045 65412436 , jens.sorensen@rsyd.dk
    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
    Interim
    Date of interim/final analysis
    28 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study will evaluate the feasibility of tacrolimus ointment in preventing lymphedema after breast cancer treatment.
    Protection of trial subjects
    The protection of clinical trial subjects is consistent with the principles set out in the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Feb 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    49
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at Odense University Hospital, Lillebælt Hospital Vejle, and Hospital of Southwest Jutland in Esbjerg from February 2020 to June 2022. Patients included at Odense University hospital were assigned to the treatment group, and patients included at Vejle and Esbjerg were allocated to the control group.

    Pre-assignment
    Screening details
    		 Inclusion took place 1-4 days prior to the scheduled axillary lymph node dissection surgery. During the course of breast cancer treatment, potential participants were screened for eligibility criteria at the outpatient clinic for each participating study site by clinical staff.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Invervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus (0.1 % tacrolimus)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 thin layer on the axilla, arm and hand daily for 12 months

    Arm title
    		 Control
    Arm description
    		 Control group not recieving any treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Invervention Control
    Started
    22
    39
    3 months
    19
    38
    6 months
    19
    39
    9 months
    19
    37
    12 months
    18
    37
    Completed
    18
    37
    Not completed
    4
    2
         Consent withdrawn by subject
    3
    -
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 61 61
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 50 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.89 ( 10.60 ) -
    Gender categorical
    Units: Subjects
        Female
    		 61 61
        Male
    		 0 0
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 26.49 ( 4.70 ) -

    End points

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    End points reporting groups
    Reporting group title
    Invervention
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 Control group not recieving any treatment

    Subject analysis set title
    Endpoints
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Data was analyzed per protocol.

    Primary: Lymphedema diagnosis

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    End point title
    		 Lymphedema diagnosis
    End point description
    End point type
    Primary
    End point timeframe
    Observed at 12 months follow up
    End point values
    		 Invervention Control
    Number of subjects analysed
    18
    37
    Units: subjects
        Yes
    7
    13
        No
    11
    24
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    Invervention v Control
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Lymphedema criteria met?

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    End point title
    		 Lymphedema criteria met?
    End point description
    Was a change of a least 10% seen in the arm at-risk
    End point type
    Secondary
    End point timeframe
    baseline to 12 months
    End point values
    		 Invervention Control
    Number of subjects analysed
    18
    37
    Units: subjects
        Yes
    3
    4
        No
    15
    33
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    Invervention v Control
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in arm volume difference

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    End point title
    		 Change in arm volume difference
    End point description
    Change in difference in arm volume for each patient fra baseline to 12 months
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Invervention Control
    Number of subjects analysed
    18
    37
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    95.22 ( 34.93 )
    76.26 ( 24.18 )
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    Invervention v Control
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: LYMPH ICF

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    End point title
    		 LYMPH ICF
    End point description
    Change in LYMPH ICF scores
    End point type
    Secondary
    End point timeframe
    baseline to 12 months
    End point values
    		 Invervention Control
    Number of subjects analysed
    18
    37
    Units: Arbitary unit
        arithmetic mean (standard deviation)
    5.14 ( 3.40 )
    10.80 ( 2.37 )
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    Invervention v Control
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: DASH

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    End point title
    		 DASH
    End point description
    change in DASH scores
    End point type
    Secondary
    End point timeframe
    Baseline to 12 months
    End point values
    		 Invervention Control
    Number of subjects analysed
    18
    37
    Units: Arbitary unit
        arithmetic mean (standard deviation)
    8.51 ( 2.18 )
    7.41 ( 1.53 )
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    Invervention v Control
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: L-Dex

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    End point title
    		 L-Dex [1]
    End point description
    Any assessed for the intervention group
    End point type
    Secondary
    End point timeframe
    baseline to 12 months
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only the intervention group was assessed with l-dex
    End point values
    		 Invervention
    Number of subjects analysed
    18
    Units: Arbitary unit
        arithmetic mean (standard deviation)
    5.98 ( 2.51 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-12 months
    Adverse event reporting additional description
    Data collected throughout the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 The intervention group was instructed to apply a thin layer of 0.1% tacrolimus ointment to the arm, hand, and axilla for a period. of 12 months starting from the day after surgery.

    Serious adverse events
    		 intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 22 (22.73%)
    Skin and subcutaneous tissue disorders
    Flushing
    Additional description: In relation to alcohol intake
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Folliculitis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Infection
    Additional description: postoperative skin infection in the axilla
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    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
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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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