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    Summary
    EudraCT Number:2017-000268-14
    Sponsor's Protocol Code Number:170113
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-20
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2017-000268-14
    A.3Full title of the trial
    Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D supplementation for patients with terminal cancer diagnosis - The patients will receive randomly either Vitamin D or inactive substance (placebo). Neither the patients or study personnel will know what treatment the patients will receive.
    A.3.2Name or abbreviated title of the trial where available
    Palliative-D
    A.4.1Sponsor's protocol code number170113
    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 SponsorASIH Stockholm Södra, Långbro Park
    B.1.3.4CountrySweden
    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 supportThe Swedish Cancer Society
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportALF-funding
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRenapharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASIH Stockholm Södra, Långbro Park
    B.5.2Functional name of contact pointLinda Björkhem-Bergman
    B.5.3 Address:
    B.5.3.1Street AddressBergtallsvägen 12
    B.5.3.2Town/ cityÄlvsjö
    B.5.3.3Post code125
    B.5.3.4CountrySweden
    B.5.6E-maillinda.bjorkhem-bergman@ki.se
    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 Detremin
    D.2.1.1.2Name of the Marketing Authorisation holderRenapharma AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Oral drops, 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 INNCHOLECALCIFEROL
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE
    D.3.9.4EV Substance CodeSUB42623
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 drops, 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
    Any type of incurable cancer

    E.1.1.1Medical condition in easily understood language
    Any type of incurable cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The primary objective is to test the hypothesis vitamin D supplementation for 12 weeks reduces opioid consumption.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to test the hypothesis that vitamin D supplementation for 12 weeks leads to decline in antibiotic consumption, improvement in quality of life and improvement in fatigue. The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied. We will also investigate the change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897).

    The safety objective is to verify that the use of vitamin D is safe and tolerable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
    2. Incurable cancer patients with any type of cancer. They could have ongoing oncological treatment but only with palliative intention. No patients with ongoing oncological treatment with curative intended treated will be included.
    3. The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
    4. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
    5. 25 OHD < 50 nmol/L.
    6. Men and women aged ≥18.
    7. Signed ’informed consent’.
    E.4Principal exclusion criteria
    1. Ongoing vitamin D or calcium supplementation at the time for inclusion.
    2. Serum level of 25-OH vitamin D3 >50 nmol/L.
    3. Known sarkoidosis.
    4. Treament with tiazides.
    5. Primary hyperparathyroidism.
    6. Hypercalcaemia (verified by a laboratory result younger than 2 month).
    7. Plans to leave the Stockholm county within 12 weeks of inclusion.
    8. History of kidney stones.
    9. Taking part of another clinical study involving drugs.
    10. Hypersensivity to cholecalciferol and/or any of the excipients.
    11. Other criteria that could jeopardize the study or its intention as judged by the investigator.
    12. Not being able to perform EORTC-QLQ-C15-PAL or ESAS.
    E.5 End points
    E.5.1Primary end point(s)
    1) The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo groups, based on 4 measurements with 4 week intervals.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Opioid dose, translated to fentanyl per hour measured at baseline and at week 4, 8 and 12.
    E.5.2Secondary end point(s)
    1) Decline in antibiotic consumption (expressed as % of days with antibiotics during the last 4 weeks) based on measurements at baseline, week 4, 8 and 12.
    2) Improvement in quality of life measured with EORTC-QLQ-PAL15 at screening and after 12 weeks
    3) Improvement in fatigue measured with EORTC-QLQ-PAL15 at screening and after 12 weeks
    4) Improvement in symptom burden measured with ESAS.
    5) Levels of 25-OHD in serum after 12 weeks of treatment.
    6) The change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D, VDR(TaqI and FoqI), GC (Rs2282679, CYP2R1 (Rs2060793), CYP27B (Rs10877012) and CYP24A1 (rs Rs6013897).
    7) The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.
    2) Quality of Life measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks.
    3) Fatigue measured with EORTC-QLQ-C15-PAL at screening and after 12 weeks.
    4) Improvement in symptom burden measured with ESAS at screening and at week 4, 8 and 12.
    5) 25-hydroxyvitamin D levels in blood measured at screening and after 12 weeks.
    6) The change in opiod dose measured at baseline, week 4, 8 and 12 related to genetic polymorphism in genes measured at screening.
    7) Frequency of AE during the whole study, and S-calcium will be controlled in all subjects at screening, at week 4, 8 and 12 and U-calcium in selected cases.
    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 Yes
    E.6.4Safety Yes
    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) No
    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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    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: 101
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 153
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with incurable cancer.
    F.4 Planned number of subjects to be included
    F.4.1In the member state254
    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)
    All patients will be offered vitamin D treatment after the study according to available guidelines.

    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 Decision2017-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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