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    Clinical Trial Results:
    Tocotrienol as a nutritional supplement in patients with advanced pulmonal cancer

    Summary
    EudraCT number
    		 2015-002742-32
    Trial protocol
    		 DK  
    Global end of trial date
    09 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Apr 2021
    First version publication date
    10 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Toco-Pulm
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02644252
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark,
    Public contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@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
    Final
    Date of interim/final analysis
    01 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective is to investigate the effect of tocotrienol as a nutritional supplement in combination with first-line chemotherapy on progression free survival (PFS) in patients with advanced NSCLC
    Protection of trial subjects
    Anti-emetics and analgesics administered as needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2016
    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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    27
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Danish patients with advanced non-small cell lung cancer recruited in the outpatient setting.

    Pre-assignment
    Screening details
    		 Patients with locally advanced non-small cell lung cancer were screened on an outpatient basis.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard treatment + placebo
    Arm description
    		 Combination chemotherapy with platinum
    Arm type
    		 Placebo

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2

    Arm title
    		 Standard treatment + tocotrienol
    Arm description
    		 Combination chemotherapy with platinum + tocotrienol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocotrienol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Daily: Tocotrienol 300 mg x 3

    Number of subjects in period 1
    		Standard treatment + placebo Standard treatment + tocotrienol
    Started
    40
    38
    Completed
    30
    30
    Not completed
    10
    8
         Consent withdrawn by subject
    3
    -
         Adverse event, non-fatal
    7
    8

    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
    		 78 78
    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)
    		 27 27
        From 65-84 years
    		 51 51
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 40 40
        Male
    		 38 38
    Subject analysis sets

    Subject analysis set title
    Arm A, standard + placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with advanced lung cancer receiving standard chemotherapy + placebo

    Subject analysis set title
    Arm B, standard + tocotrienol
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with advanced lung cancer receiving standard chemotherapy + tocotrienol

    Subject analysis sets values
    		 Arm A, standard + placebo Arm B, standard + tocotrienol
    Number of subjects
    40
    38
    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)
    13
    14
        From 65-84 years
    25
    26
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    18
    20
        Male
    20
    20

    End points

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    End points reporting groups
    Reporting group title
    Standard treatment + placebo
    Reporting group description
    		 Combination chemotherapy with platinum

    Reporting group title
    Standard treatment + tocotrienol
    Reporting group description
    		 Combination chemotherapy with platinum + tocotrienol

    Subject analysis set title
    Arm A, standard + placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with advanced lung cancer receiving standard chemotherapy + placebo

    Subject analysis set title
    Arm B, standard + tocotrienol
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with advanced lung cancer receiving standard chemotherapy + tocotrienol

    Primary: Progression free survival

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    End point title
    		 Progression free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    From date of randomization to progression
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The trial was ended prematurely because of a poor accrual rate
    End point values
    		 Arm A, standard + placebo Arm B, standard + tocotrienol
    Number of subjects analysed
    40
    38
    Units: Months
        number (not applicable)
    40
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Before start of each treatment cycle, i.e. every three weeks.
    Adverse event reporting additional description
    AEs graded according to CTCAE version 4.0
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Toxicity
    Reporting group description
    		 -

    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: The frequency of each non-serious event was below the 5% cut-off.
    Serious adverse events
    		 Toxicity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 78 (21.79%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences causally related to treatment / all
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences causally related to treatment / all
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Toxicity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 78 (0.00%)

    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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