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    Clinical Trial Results:
    Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy

    Summary
    EudraCT number
    		 2009-009867-70
    Trial protocol
    		 FR  
    Global end of trial date
    10 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2019
    First version publication date
    26 Jan 2019
    Other versions
    Summary report(s)
    		 HBC
    HBC

    Trial information

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    Trial identification
    Sponsor protocol code
    ET2008-048
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01246427
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CENTRE LEON BERARD
    Sponsor organisation address
    28 RUE LAENNEC, LYON, France, 69373 LYON CEDEX 08
    Public contact
    E. BLANC, CENTRE LEON BERARD - DIRECTION DE LA RECHERCHE CLINIQUE ET DE L'INNOVATION, DRCIreglementaire@lyon.unicancer.fr
    Scientific contact
    PE HEUDEL, CENTRE LEON BERARD, DRCIreglementaire@lyon.unicancer.fr
    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
    16 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of BRN01 efficacy versus placebo in reducing hot flash score after 4 weeks of treatment.
    Protection of trial subjects
    Several follow-up (consultation with physician) Provision to patient of a self-assessment booklet Provison to patient of evaluation questionnaire Provison to patient of satisfaction questionnaire
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2010
    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
    France: 138
    Worldwide total number of subjects
    138
    EEA total number of subjects
    138
    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)
    138
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The inclusion will take place during a follow-up consultation of the patient by her oncologist, if it reports in particular BC appearing crippling, and having a negative impact on its quality of life. The investigator will verify the eligibility of the patient, inform her about the study and collect her consent to participation

    Pre-assignment
    Screening details
    		 Clinical assessment

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

    Arms
    Arm title
    		 Run in phase
    Arm description
    		 This step is intended to select patients whose hot flashes would be particularly disabling, eliminating patients "responders" to placebo, and only retain for the rest of the trial those who could benefit from their participation.
    Arm type
    		 Selection of patient

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral use, tablet

    Number of subjects in period 1
    		Run in phase
    Started
    138
    Completed
    138
    Period 2
    Period 2 title
    Comparative evaluation phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental drug
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ACTHEANE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg milligram(s) per day

    Arm title
    		 Comparative arm
    Arm description
    		 Comparative arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral use, tablet

    Number of subjects in period 2
    		Experimental drug Comparative arm
    Started
    65
    73
    Completed
    65
    73

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Run in phase
    Reporting group description
    		 This step is intended to select patients whose hot flashes would be particularly disabling, eliminating patients "responders" to placebo, and only retain for the rest of the trial those who could benefit from their participation.

    Reporting group values
    		 Run in phase Total
    Number of subjects
    		 138 138
    Age categorical
    Adults >= 18 years
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 138 138
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Adults >= 18 years
    Units: years
        median (full range (min-max))
    		 51 (37 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 69 69
        Male
    		 69 69

    End points

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    End points reporting groups
    Reporting group title
    Run in phase
    Reporting group description
    		 This step is intended to select patients whose hot flashes would be particularly disabling, eliminating patients "responders" to placebo, and only retain for the rest of the trial those who could benefit from their participation.
    Reporting group title
    Experimental drug
    Reporting group description
    		 -

    Reporting group title
    Comparative arm
    Reporting group description
    		 Comparative arm

    Primary: Treatment efficiency

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    End point title
    		 Treatment efficiency
    End point description
    Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period). Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).
    End point type
    Primary
    End point timeframe
    4th weeks of treatement
    End point values
    		 Experimental drug Comparative arm
    Number of subjects analysed
    65
    73
    Units: score
        median (full range (min-max))
    15 (10 to 57)
    16 (10 to 59)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Experimental drug v Comparative arm
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 8.6
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During all study period (inclusion to out of study)
    Adverse event reporting additional description
    The Investigator immediately informs the Promoter of any serious adverse events occurring during the study in a written report, whether or not they are attributable to the research.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Adverse event
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 138 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Adverse event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 138 (2.17%)
    Musculoskeletal and connective tissue disorders
    articular event
         subjects affected / exposed
    3 / 138 (2.17%)
         occurrences all number
    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? 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/30194492
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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
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