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    Clinical Trial Results:
    MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer: a pivotal phase 2, double-blind, randomized, placebo-controlled trial

    Summary
    EudraCT number
    		 2018-001705-91
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2022
    First version publication date
    20 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HEHDZ02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03716583
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark,
    Public contact
    Dennis Bregner Zetner, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, dennis.zetner@gmail.com
    Scientific contact
    Dennis Bregner Zetner, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, dennis.zetner@gmail.com
    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
    27 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if melatonin can protect against radiation injury in women receiving radiation therapy as part of their treatment of breast cancer.
    Protection of trial subjects
    n/a
    Background therapy
    		 Radiation therapy for breast cancer
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2018
    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
    Denmark: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    30
    From 65 to 84 years
    17
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion criteria Diagnosed with early breast cancer Over 49 years old Have had radical surgery Follows treatment regimens and follow-up at Rigshospitalet Exclusion criteria Inability to understand Danish Mental illness Previous therapy with ionizing radiation in the thoracic or neck area Use of bolus for radiation therapy Pregnancy

    Period 1
    Period 1 title
    Entire period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Melatonin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Transdermal use
    Dosage and administration details
    25 mg melatonin, 150 mg DMSO per 1 g cream

    Arm title
    		 Arm 2
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Transdermal use
    Dosage and administration details
    Placebo cream

    Number of subjects in period 1
    		Arm 1 Arm 2
    Started
    26
    22
    Completed
    26
    22

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 -

    Reporting group title
    Arm 2
    Reporting group description
    		 -

    Primary: RTOG-score

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    End point title
    		 RTOG-score
    End point description
    End point type
    Primary
    End point timeframe
    Once weekly for duration of trial
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    24
    22
    Units: 5
    24
    22
    Statistical analysis title
    		 t-test
    Comparison groups
    Arm 1 v Arm 2
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.041
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Three weeks follow-up after end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2021AB
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 26 (34.62%)
    5 / 22 (22.73%)
    Nervous system disorders
    Tiredness
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Garlic like breath/odor
         subjects affected / exposed
    5 / 26 (19.23%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Burning sensation
         subjects affected / exposed
    4 / 26 (15.38%)
    3 / 22 (13.64%)
         occurrences all number
    4
    3

    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? Yes
    Date
    Interruption
    Restart date
    25 Nov 2019
    Problems with GMP-license of subcontractor of pharmacy who produced drugs. We were interrupted by the Danish Medicines Agency.
    05 Jun 2020

    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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