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    Summary
    EudraCT Number:2015-002202-37
    Sponsor's Protocol Code Number:2015-115
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-002202-37
    A.3Full title of the trial
    Pilot study: Is concomitant administration of lidocaine during oxaliplatin infusion able to prevent pain as a result of oxaliplatin induced acute neuropathy?
    Plot studie: Is het gelijktijdig toedienen van lidocaine gedurende oxaliplatin infusie in staat om pijn als gevolg van oxaliplatin geïnduceerde acute neuropahie te voorkomen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is concomitant administration of lidocaine during oxaliplatin infusion able to prevent acute nervepain as a result of oxaliplatin?
    Is het gelijktijdig toedienen van lidocaine gedurende oxaliplatin infusie in staat om zenuwpijn als gevolg van oxaliplatin te voorkomen
    A.3.2Name or abbreviated title of the trial where available
    LiON
    LiON
    A.4.1Sponsor's protocol code number2015-115
    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 Sponsorradboudumc
    B.1.3.4CountryNetherlands
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointHead of department Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailKris.Vissers@radboudumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Lidocaine Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameLidocaine
    D.3.2Product code RVG 51673
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute oxaliplatin induced neuropathy
    Acute neuroapthie als gevolg van oxaliplatin
    E.1.1.1Medical condition in easily understood language
    Acute oxaliplatin induced nerve pain
    Acute zenuwpijn als gevolg van oxaliplatin
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    To evaluate the efficacy of low dose intravenously lidocaine in comparison with placebo in terms of pain relief after the first oxaliplatin administration measured by a numeric rating scale (NRS 0-10
    Beoordelen van het analgetisch effect van lage dosis intraveneus lidocaïne in vergelijking met placebo na de eerste toediening van oxaliplatin gemeten middels een numerieke beoordelingsschaal (NRS 0-10).
    E.2.2Secondary objectives of the trial
    1. Difference in pain scores between placebo and lidocaine administered concomitant with oxaliplatin during and after all cycles of oxaliplatin administration.
    2. Does lidocaine administered attenuates systemic inflammatory response measured by plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1β, TNF-α and ICAM-1?
    3. To evaluate if lidocaine influences quantative sensory testing (pressure algometry and ice-bucket).
    4. To evaluate if lidocaine reduces chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire.
    5. Cumulative oxaliplatin dosage.
    6. Cumulative analgesics usage.
    7. Other secondary outcomes consists of quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function and DNA/RNA biobanking.
    1. Beoordelen van verschil in pijnscores tijdens en na alle cycli van oxaliplatin tussen placebo en lage dosis intraveneus lidocaïne
    2. Verminderd lidocaïne de systemische ontstekingsreactie gemeten door plasma cytokine levels van interleukine (IL) -6, IL-8, IL-10, IL-1β, TNF-α en ICAM-1?
    3. Beoordelen of lidocaïne invloed heeft op QST-metingen (druk algometrie en ijswater test).
    4. Beoordelen of lidocaïne de chronische neuropathische veranderingen als gevolg van oxaliplatin beïnvloedt, gemeten middels de klinische totale neuropathie score (TNS), neurofysiologische geleidings studies, huid biopsie en middels een NCI-CTC en EORTC QLQ-CIPN20 vragenlijst.
    5. Cumulatieve oxaliplatin dosering.
    6. Cumulatieve analgetica gebruik.
    7. Andere secundaire uitkomstmaten zijn : de kwaliteit van leven gemeten middels de EORTC QLQ-C30 en de patiënt gerapporteerde uitkomstvariabelen voor kracht en sensorische functie en DNA/RNA biobanking
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with stage II to IV colorectal adenocarcinoma, who are scheduled to receive 6-8 cycles of oxaliplatin 130 mg/m2 every 3 weeks .
    Patiënten met stadium II tot IV colrectaal adenocarcinoom, welke staan gepland voor 6-8 cycli van oxaliplatin elke 3 weken 130mg/m2
    E.4Principal exclusion criteria
    Receiving other chemotherapeutics in medical history
    Allergy to amide type of local anesthetics
    Recent myocardial ischemia (<6 months)
    Renal function disorders (MDRD < 60)
    Liver failure (bilirubine > 1,5x upper limit of normal)
    Adequate hematologic parameters
    Hypokaliemia
    Pregnancy or lactating
    Use of anti-arythmic drugs (flecainide)
    Pre-existing form of neuropathy (polyneuropathy or small fibre neuropathy)
    History of chronic pain and opioid use
    Risk factors for CIPN: alcoholism, diabetes mellitus
    No written informed consent by patient
    Patiënten die andere chemotherapeutica hebben gehad in verleden
    Allergie voor soort lokale anesthetica amide
    Recent myocard ischemie (<6 maanden)
    Nierfunctiestoornissen (MDRD <60)
    Leverfalen (bilirubine> 1,5x bovengrens van normaal)
    Adequate hematologische parameters
    Hypokaliëmie
    Zwangerschap of borstvoeding
    Het gebruik van anti-aritmica (bv: flecainide)
    Reeds bestaande vorm van neuropathie (polyneuropathie of kleine vezels neuropathie)
    Voorgeschiedenis van chronische pijn en het gebruik van opioïden
    Risicofactoren voor CIPN: alcoholisme, diabetes mellitus
    Geen informed consent verkregen van patiënt
    E.5 End points
    E.5.1Primary end point(s)
    The difference in NRS scores for pain after the first infusion of oxaliplatin and administration of studymedication.
    The aim is a reduction of 3 points of NRS
    Het verschil NRS scores voor pijn na de eerste kuur oxaliplatin en inlopen van de studiemedicatie.
    Het doel is een reductie van 3 punten van de NRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Directly after administration of the studymedication
    Direct na toedienen van de studiemedicatie
    E.5.2Secondary end point(s)
    1. Difference in pain scores after all cycles of oxaliplatin administration.
    2. plasma cytokine levels of interleukin (IL)-6, IL-8, IL-10, IL-1β, TNF-α and ICAM-1 before and after first dose of oxaliplatin?
    3. Results from quantative sensory testing (pressure algometry and ice-bucket).
    4. Chronic neuropathic changes measured by the clinical total neuropathy score (TNS), neurophysiologic conductions studies, skin biopsy and measured by a NCI-CTC and EORTC QLQ-CIPN20 questionnaire.
    5. Cumulative oxaliplatin dosage.
    6. Cumulative analgesics usage.
    7. Quality of life improvements measured by EORTC QLQ-C30 and patient reported outcome variables for strength and sensory function.
    1. Verschil in pijnscores tijdens en na alle cycli van oxaliplatin
    2. plasma cytokine levels van interleukine (IL) -6, IL-8, IL-10, IL-1β, TNF-α en ICAM-1 voor en na eerste oxaliplatin?
    3. Invloed op QST-metingen (druk algometrie en ijswater test).
    4. chronische neuropathische veranderingen gemeten middels de klinische totale neuropathie score (TNS), neurofysiologische geleidings studies, huid biopsie en middels een NCI-CTC en EORTC QLQ-CIPN20 vragenlijst.
    5. Cumulatieve oxaliplatin dosering.
    6. Cumulatieve analgetica gebruik.
    7. Kwaliteit van leven gemeten middels de EORTC QLQ-C30 en de patiënt gerapporteerde uitkomstvariabelen voor kracht en sensorische functie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pain scores and patient reported outcomes: before and till 5 days after oxaliplatin infusion
    Questionnaires EORTC-CIPN20 and NCI-CTC at baseline, before each oxaliplatin infusion and at 3 months follow up. EORTC QLQ-C30 at baseline at 3 months follow up.
    Physical examination (QST, sock/glove like distribution, and clinical total neuropathy score): at baseline, before fourth and eight oxaliplatin infusion and at 3 months follow up
    Neurophysiologis studies: at baseline, before fourth and eight oxaliplatin infusion and 3 months follow up
    Skin biopt at baseline and at 3 months follow up
    Cumulative oxaliplatin dose and analgesics usage at 3 months
    Verschil in NRS vóór en na de volgende oxaliplatin infusies en bij 3 maanden follow up.
    Cytokines en ICAM-1: voor en na de 1e infusie van oxaliplatin.
    Vragenlijsten: NCI-CTC en EORTC-CIPN20 bij aanvang, vóór elke oxaliplatin infusie en bij 3 maanden follow-up
    EORTC QLQ-C30 bij aanvang en 3 maanden follow up.
    Patiënt gerapporteerde uitkomsten: bij aanvang, na elke kuur en bij 3 maanden follow up.
    Lichamelijk onderzoek:
    QST, groote sok/handschoen en klinische totale neuropathie score bij aanvang, vóór 4e en 8e oxaliplatin infusie en bij 3 maanden follow-up.
    Neurofysiologische studies
    bij aanvang, na de 4e en 8e oxaliplatin infusie en bij 3 maanden follow-up
    Huidbiopt op bij aanvang en 3 maanden follow-up
    Cumulatieve oxaliplatin dosis en analgetica bij 3 maanden follow-up
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    The end point of the trial is after the last patient has fully undergone the research procedure. 24 Patients will be included
    Het eindpunt van de studie is nadat de 24e patient de volledige studieprocedure heeft ondergaan
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state24
    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)
    None
    geen
    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 Decision2015-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-06
    P. End of Trial
    P.End of Trial StatusOngoing
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