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    Summary
    EudraCT Number:2013-003478-29
    Sponsor's Protocol Code Number:VIDAFACT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003478-29
    A.3Full title of the trial
    The effect on quality of life of Vitamin D administration for advanced cancer treatment. A randomized controlled trial
    El efecto sobre la calidad de vida de la administración de Vitamina D para el tratamiento del cáncer avanzado. Un ensayo clínico controlado avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect on quality of life of Vitamin D administration for advanced cancer treatment.
    El efecto sobre la calidad de vida de la administración de Vitamina D para el tratamiento del cáncer avanzado.
    A.3.2Name or abbreviated title of the trial where available
    VIDAFACT
    VIDAFACT
    A.4.1Sponsor's protocol code numberVIDAFACT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMaria Nabal Vicuña (Paliative Care Supportive Team-Hospital Universitari Arnau de Vilanova de Lleida)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPaliative Care Supportive Team
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaria Nabal Vicuña (Paliative Care Supportive Team)
    B.5.2Functional name of contact pointClinical Trials Office
    B.5.3 Address:
    B.5.3.1Street AddressRovira Roure nº80
    B.5.3.2Town/ cityLleida
    B.5.3.3Post code25198
    B.5.3.4CountrySpain
    B.5.4Telephone number++34973705236
    B.5.5Fax number++34973248754
    B.5.6E-mailf.ibanez.alarcon@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vitamine D3 Kern Pharma
    D.2.1.1.2Name of the Marketing Authorisation holderKern Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVITAMINA D3 or COLECALCIFEROL
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVitamina D3
    D.3.9.2Current sponsor codeHospital Universitari Arnau de Vilanova de Lleida
    D.3.9.3Other descriptive nameCOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The effect on quality of life of Vitamin D administration for advanced cancer treatment. A randomized controlled trial
    El efecto sobre la calidad de vida de la administración de Vitamina D para
    el tratamiento del cáncer avanzado.Un ensayo clínico controlado aleatorizado
    E.1.1.1Medical condition in easily understood language
    The effect on quality of life of Vitamin D administration for advanced cancer treatment.
    El efecto sobre la calidad de vida de la administración de Vitamina D para
    el tratamiento del cáncer avanzado
    E.1.1.2Therapeutic area Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance patient?s reported health-related quality of
    life of these patients.
    Evaluar la eficacia de una nueva modalidad terapéutica con vitamina D3 para mejorar la calidad de vida relacionada con la salud valorada por el paciente
    E.2.2Secondary objectives of the trial
    1) Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance physical performance (Karnofsky and
    PPS scales).
    2) Evaluate the efficacy of a new therapeutic modality with vitamin D3 to enhance perceived fatigue (FACT-F).
    3) Evaluate the efficacy of the proposed therapeutic modality with vitamin D3 to achive serum levels of 25-hydroxy vitamin
    D above 30 ng/mL.
    4) Evaluate the effect on tumor biomarkers.
    5) Explore the relationship between vitamin D treatment compliance and serum levels of vitamin D.
    5) Explore the relationship between serum levels of vitamin D and renal function.
    6) Explore the dose-response relationship in the group of patients with vitamin D3 for the main outcome.
    7) Assess the cost-utility of the proposed therapeutic modality with vitamin D3.
    1) Evaluar la eficacia para mejorar la capacidad funcional (Karnofsky & PPS scales);
    2) Evaluar la eficacia para disminuir la fatiga (FACT-F);
    3) Evaluar la eficacia para alcanzar niveles séricos de 25-
    hidroxivitamina D por encima de 30 ng/mL;
    4) Evaluar el efecto sobre biomarcadores tumorales;
    5) Explorar la relación entre el cumplimiento del tratamiento con vitamina D3 y los niveles séricos de vitamina D;
    6) Explorar la relación entre los niveles séricos de vitamina D y la función renal;
    7) Explorar la relación dosis-respuesta en el grupo con vitamina D sobre la calidad de vida;
    8) Evaluar el coste-utilidad de la intervención (EQ5D).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients satisfying inclusion criteria will be randomly assigned to receive vitamin D or placebo. Eligible patients
    will be adults (18 years or older) having a locally advanced or metastatic or inoperable solid cancer under palliative care,
    upon signed informed consent
    Los pacientes que cumplan con los criterios de inclusión se asignarán aleatoriamente a vitamina D
    o placebo. Los pacientes elegibles son adultos (18 años o más) con un cáncer sólido avanzado, tanto localizado
    como metastático, inoperable y en cuidados paliativos que firme el consentimiento informado
    E.4Principal exclusion criteria
    Exclusion criteria will be having a Karnofsky < 30%, being pregnant or breast-feeding
    females, undergoing severe liver or renal (GRF<60) failure, having a cognitive deterioration (more than 5 mistakes in
    Pfeiffer test)., suffering from significant (more than 6 out of 10 in a Numerical Rating Scale 0:10) pain, dyspnea, nausea or
    vomits, or having received chemo or radiation therapy within the last 3 weeks prior to inclusion, or with the possibility of
    iniciating a new cycle of chemo or radiation therapy within a period of 6 weeks after their inclusion date.
    Criterios de exclusión serán tener un Karnofsky < 30%, estar embarazada o en período de lactancia, sufrir fallo renal
    (GRF<60) o hepático severo, mostrar un deterioro cognitivo (más de 5 errores en la prueba de Pfeiffer),
    sufrimiento significativo (más de 6 sobre 10 en una escala numérica 0:10) de dolor, disnea, náuseas, vómitos, o
    haber recibido radio o quimioterapia (R-QT) en las últimas 3 semanas previas a la inclusión o con perspectivas
    de iniciar un nuevo ciclo de R-QT en las 6 semanas posteriores a la fecha de inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Quality of life questionnaires EORTC QLQ-C15-PAL
    Cuestionarios de calidad de vida EORTC QLQ-C15-PAL
    E.5.1.1Timepoint(s) of evaluation of this end point
    FACT-F questionnaires, serum 25-hydroxyvitamin, tumor biomarkers, cumpliemto treatment, relationship of vitamin D serum levels with renal function, EQ5D questionnaire.
    Cuestionarios FACT-F, niveles séricos de 25 -hidroxivitamina, biomarcadores tumorales, cumpliemto de tratamiento, relación de niveles séricos de vitamina D con función renal, cuestionario EQ5D.
    E.5.2Secondary end point(s)
    Day 0, day 14, day 28 and day 42
    Día 0, día 14, día 28 y día 42
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, day 14, day 28 and day 42
    Día 0, día 14, día 28 y día 42
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Patients will be in treatment with trial medication since day 14 to 28 and then made ??two visits post treatment (day 28 and day 42), it will be completed for each patient study.
    Los pacientes estaran en tratamiento con la medicación del ensayo des del día 14 hasta el 28 y después se realizarán dos visitas post tratamiento (día 28 y día 42), se dará por finalizado el estudio para cada paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 274
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state274
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The duration of study treatment from day 14 to day 28
    La duración del tratamiento de estudio es desde el día 14 hasta el día 28
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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