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    Clinical Trial Results:
    Advances in the management of mandibular osteoradionecrosis: Pentoxyfilline and Tocopherol as medical treatment.

    Summary
    EudraCT number
    		 2014-004975-22
    Trial protocol
    		 ES  
    Global end of trial date
    31 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Sep 2021
    First version publication date
    19 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ORN-2014-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, 34 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Maxillofacial Department, Oral and Maxillofacial Surgery Department of Vall d'Hebron Hospital, 34 620684875, miryam-martos@hotmail.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
    31 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Healing of mandibular osteoradionecrosis in patients irradiated for head and neck cance after treatment with Pentoxifilina and Tocopherol (PENTO)
    Protection of trial subjects
    A mandibular TC was done if any suspects of clinical deterioration were detected. Antibiotic tretament was started in case of confirmation of an infection after microbiologal examination of exudates
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2015
    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
    Spain: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    After signing consent, a simple randomization was done, by giving a letter to the patient where the tretament groups was especified. Patient and clinicians knew at every moment the group to which the patient was assigned

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PTX Tocopherol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pentoxifylline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral ingesta of 800 mg pentoxifylline (2x 400 mg tablets), daily, between 6 and 18 months

    Investigational medicinal product name
    Tocopherol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 UI tocopherol (2x 400UI tablets +1x 200)UI tablet), daily, between 6 and 18 months

    Arm title
    		 Control no treatment
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		PTX Tocopherol Control no treatment
    Started
    13
    12
    Completed
    13
    12

    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
    		 25 25
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 11 11
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    PTX Tocopherol
    Reporting group description
    		 -

    Reporting group title
    Control no treatment
    Reporting group description
    		 -

    Primary: Intraoral ulceration reduction

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    End point title
    		 Intraoral ulceration reduction
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 PTX Tocopherol Control no treatment
    Number of subjects analysed
    13
    12
    Units: square millimiter
        median (full range (min-max))
    -100 (-108 to -50)
    -2 (-21 to 0)
    Statistical analysis title
    		 Bone exposition
    Comparison groups
    PTX Tocopherol v Control no treatment
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Oral aperture

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    End point title
    		 Oral aperture
    End point description
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 PTX Tocopherol Control no treatment
    Number of subjects analysed
    13
    12
    Units: millimeter(s)
        median (full range (min-max))
    25.0 (16.0 to 34.0)
    27.5 (19.5 to 30.8)
    Statistical analysis title
    		 Oral aperture
    Comparison groups
    PTX Tocopherol v Control no treatment
    Number of subjects included in analysis
    25
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 25 (8.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 25 (8.00%)
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2

    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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