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    Clinical Trial Results:
    Prospective, randomized, controlled, open-label study evaluating quality of life in patients with advanced malignant tumors with and without “add-on” homeopathy

    Summary
    EudraCT number
    		 2011-000739-97
    Trial protocol
    		 AT  
    Global end of trial date
    20 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2019
    First version publication date
    22 Dec 2019
    Other versions
    Summary report(s)
    		 Abstract
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    HINC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01509612
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Prof. Frass, Med. Univ. Wien, 0043 1404004506, michael.frass@meduniwien.ac.at
    Scientific contact
    Prof. Frass, Med. Univ. Wien, 0043 1404004506, michael.frass@meduniwien.ac.at
    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
    20 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Reveal and describe the difference in Qol and SWB, in patient groups receiving standard treatment and “add on” homeopathic treatment. The null hypothesis is that “add-on” homeopathic treatment does not create a benefit for cancer patients with regard to QoL and SWB.
    Protection of trial subjects
    No specific measures that were put in place to protect trial subjects.
    Background therapy
    		 Classical conventional anti-cancer therapy in NSCLC patients
    Evidence for comparator
    		 Comparator used in the trial was placebo in order to identify any influence of a placebo.
    Actual start date of recruitment
    01 Sep 2011
    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
    Austria: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    105
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The newly diagnosed patients are recruited at the participating centers.

    Pre-assignment
    Screening details
    		 Inclusion criteria are: Patients older than 18 years suffering from NSCLC stage IV or IIIB, IIIC diagnosed within the last 8 weeks. Exclusion criteria are: Patients not willing to sign informed consent and pregnant patients; major surgery within 4 weeks or chest irradiation wit

    Period 1
    Period 1 title
    overall trial (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
    Blinding implementation details
    placebo controlled trial. no difference between verum and placebo in the physicochemical properties of the study drugs.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 participants received homeopathic globules and dilutions for treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Homeopathic globules and dilutions
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid, Granules
    Routes of administration
    Sublingual use
    Dosage and administration details
    one dose daily

    Arm title
    		 placebo
    Arm description
    		 placebo control
    Arm type
    		 Placebo

    Investigational medicinal product name
    Homeopathic globules and dilutions
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules, Oral liquid
    Routes of administration
    Sublingual use
    Dosage and administration details
    one dose daily, placebo controle

    Arm title
    		 No Intervention arm
    Arm description
    		 Control group for placebo and verum group
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Verum placebo No Intervention arm
    Started
    51
    47
    52
    Completed
    51
    47
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 150 150
    Age categorical
    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)
    		 105 105
        From 65-84 years
    		 45 45
        85 years and over
    		 0 0
        Adults
    		 0 0
        Adults_older
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ± 8.9 -
    Gender categorical
    Units: Subjects
        Female
    		 69 69
        Male
    		 81 81
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population was analyzed

    Subject analysis sets values
    		 ITT
    Number of subjects
    150
    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)
    105
        From 65-84 years
    45
        85 years and over
    0
        Adults
    0
        Adults_older
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.2 ± 8.9
    Gender categorical
    Units: Subjects
        Female
    69
        Male
    81

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 participants received homeopathic globules and dilutions for treatment

    Reporting group title
    placebo
    Reporting group description
    		 placebo control

    Reporting group title
    No Intervention arm
    Reporting group description
    		 Control group for placebo and verum group

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population was analyzed

    Primary: EORTC Quality of life

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    End point title
    		 EORTC Quality of life [1]
    End point description
    baseline - 9 weeks - 18weeks
    End point type
    Primary
    End point timeframe
    18 weeks per subject
    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: This Endpoint was not recorded for the No-Intervention group. Only mortality was investigated for this group.
    End point values
    		 Verum placebo ITT
    Number of subjects analysed
    51
    47
    Units: score
        arithmetic mean (standard deviation)
    46.6 ± 25.8
    51.2 ± 28
    48.8 ± 26.8
    Statistical analysis title
    		 Primary Endpoint
    Statistical analysis description
    T-Test
    Comparison groups
    Verum v placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.397
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Verum placebo No Intervention arm ITT
    Number of subjects analysed
    51
    47
    52
    150
    Units: Deaths
    28
    36
    45
    109
    Statistical analysis title
    		 Verum vs. placebo
    Comparison groups
    Verum v placebo v ITT
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 verum vs. no Intervention
    Comparison groups
    Verum v No Intervention arm v ITT
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Placebo vs. No Intervention
    Comparison groups
    placebo v No Intervention arm v ITT
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.154
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Placebo and Verum vs. no intervention
    Statistical analysis description
    combined analysis of all subjects who received either placebo or verum versus no intervention
    Comparison groups
    No Intervention arm v placebo v Verum v ITT
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 months
    Adverse event reporting additional description
    On the basis of the investigated products (additive globules and dilutions to regular anticancer therapy) only adverse drug reactions have been recorded and documented. Adverse as such were not recorded and documented. Mortality was defined as a secondary endpoint and therefore presented in the endpoint section.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICd
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 5%
    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: As mentioned in the explanation. Based on the nature of the additives used in this trial (globules and dilution) only adverse drug reactions, but no adverse events were documented in the course of the trial. However, mortality was defined as an endpoint and is presented in the respective section.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2011
    Patients with high-risk mutations were excluded from participation in the trial. The No-Intervention group was added to the study design to demonstrate the possible influence of placebo treatment itself

    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.
    The study duration was projected for 7 years. Recruitment was stopped thereafter.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26051564
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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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