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    The EU Clinical Trials Register currently displays   41448   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-003176-40
    Sponsor's Protocol Code Number:CHEMOCIM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003176-40
    A.3Full title of the trial
    Randomised, clinical trial, controlled, open-label, multicenter, non-profit study to evaluate the superiority of a complementary treatment with additional Homeopathic Medicines and Acupuncture / Auriculotherapy compared to an active control group with only Cognitive Rehabilitation and Nutritional Advice.
    Studio clinico, controllato, randomizzato, in aperto, multicentrico, no-profit, per valutare la superiorità di un trattamento complementare con Medicinali Omeopatici e Agopuntura/Auricoloterapia addizionali rispetto ad un gruppo di controllo attivo con sola Riabilitazione Cognitiva e Consigli Nutrizionali.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of anticancer therapy-related cognitive impairment in breast cancer patients and evaluation of integrated therapy effects with rehabilitation exercises, diet and add-on complementary medicine
    Valutazione del deterioramento cognitivo correlato alla terapia antitumorale nei pazienti con carcinoma mammario e valutazione degli effetti della terapia integrata con esercizi di riabilitazione, dieta e medicina complementare aggiuntiva
    A.3.2Name or abbreviated title of the trial where available
    CHEMOCIM
    CHEMOCIM
    A.4.1Sponsor's protocol code numberCHEMOCIM
    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 SponsorAZIENDA USL TOSCANA NORD OVEST
    B.1.3.4CountryItaly
    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 supportRegione Toscana (Bando Ricerca Salute 2018 per la ricerca indipendente)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL Toscana Nord Ovest
    B.5.2Functional name of contact pointTask Force Sperimentazioni Clinche
    B.5.3 Address:
    B.5.3.1Street Addressviale Alfieri, 36
    B.5.3.2Town/ cityLivorno
    B.5.3.3Post code57124
    B.5.3.4CountryItaly
    B.5.6E-mailsperimentazioni.cliniche@uslnordovest.toscana.it
    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 GUNA BDNF 4CH 30ML GTT
    D.2.1.1.2Name of the Marketing Authorisation holderGuna Spa
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBrain-Derived Neuritrophic Factor
    D.3.2Product code [801846116]
    D.3.4Pharmaceutical form Oral drops
    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.3.9.2Current sponsor codeBrain-Derived Neuritrophic Factor
    D.3.9.3Other descriptive nameBrain-Derived Neuritrophic Factor
    D.3.10 Strength
    D.3.10.1Concentration unit DF dosage form
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 PHOSPHORUS 30CH GR
    D.2.1.1.2Name of the Marketing Authorisation holderBoiron Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePHOSPHORUS 30CH
    D.3.2Product code [800024224]
    D.3.4Pharmaceutical form Pillules
    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.3.9.2Current sponsor codePHOSPHORUS
    D.3.9.3Other descriptive nameFOSFORO BIANCO
    D.3.10 Strength
    D.3.10.1Concentration unit DF dosage form
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary diagnosis of breast cancer (stage: I-III A) treated with adjuvant chemotherapy and / or endocrine therapy after surgical treatment.
    Diagnosi primaria di cancro alla mammella (stadio: I-III A) trattato con chemioterapia adiuvante e/o terapia endocrina dopo il trattamento chirurgico.
    E.1.1.1Medical condition in easily understood language
    Breast cancer operated and treated with chemotherapy and / or hormone therapy
    Tumore alla mammella operato e trattato con chemioterapia e/o ormonoterapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038604
    E.1.2Term Reproductive system and breast disorders
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the effectiveness of an integrated medicine treatment (Aug / Omeo / Ago + Omeo) additional to the only standard treatment on cognitive disorders in patients with breast cancer.
    Confrontare l’efficacia di un trattamento di Medicina Integrata (Ago/Omeo/Ago+Omeo) aggiuntivo rispetto al solo trattamento standard sui disturbi cognitivi in pazienti affette da carcinoma mammario.
    E.2.2Secondary objectives of the trial
    a) Assess the possible effect, and the relative influence, of anxiety and mood in cognitive disorders through self-administered questionnaires;
    b) Measure the serum levels of brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha at the base-line and 10 months after enrollment and start of therapy;
    c) Evaluate any changes in the quality of life at the base-line and after 6 months and 11 months in all arms of the study;
    d) Measure cognitive deficits with in-depth psychometric tests at the baseline and at the 11th month in all the arms of the study.
    a) Valutare l’eventuale effetto, e la relativa influenza, dell’ansia e del tono dell’umore sui disturbi cognitivi tramite questionari autosomministrati;
    b) Misurare i livelli sierici di brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha alla base-line e a 10 mesi dall’arruolamento e inizio della terapia;
    c) Valutare eventuali variazioni nella qualità di vita alla base-line e dopo 6 mesi e 11 mesi in tutti i bracci dello studio;
    d) Misurare i deficit cognitivi con test psicometrici approfonditi alla baseline e all’11° mese in tutti i Bracci dello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged between 18 and 65;
    Breast cancer diagnosis (stage: I-III A) within 12 months of enrollment;
    Standard dose adjuvant chemotherapy for at least 3-6 months and concluded for at least 2 months and / or endocrine therapy in progress for at least 6 months;
    Signature of Informed Consent.
    Età compresa tra 18 e 65 anni;
    Diagnosi di tumore alla mammella (stadio: I-III A) entro 12 mesi dall’arruolamento;
    Chemioterapia adiuvante a dose standard per almeno 3-6 mesi e conclusa da almeno 2 mesi e/o terapia endocrina in corso da almeno 6 mesi;
    Firma del Consenso Informato.
    E.4Principal exclusion criteria
    Known metastatic tumor;
    History of previous severe neurological or psychiatric disorders (Epilepsy, MCI, Dementia, Psychosis, etc.);
    Positive history of oncological pathology within 5 years from the date of enrollment;
    Family history of past neurological or psychiatric disorders;
    Concomitant therapies with psychoactive drugs;
    Severe needle phobia.
    Tumore in fase metastatica nota;
    Anamnesi di disturbi neurologici o psichiatrici pregressi di grado severo (Epilessia, MCI, Demenza, Psicosi, etc.);
    Anamnesi positiva per patologia oncologica entro 5 anni dalla data dell’arruolamento;
    Anamnesi famigliare di disturbi neurologici o psichiatrici pregressi;
    Terapie concomitanti con farmaci psicoattivi;
    Grave fobia degli aghi.
    E.5 End points
    E.5.1Primary end point(s)
    1. the self-administered questionnaire on subjectively perceived cognitive symptoms (FACT-Cog) at baseline, at 6 months and after 11 months in all arms of the study;
    2. psychometric tests (Brief Cognitive State Exam -EBSC-, Frontal Assessment Battery -FAB-, Phonemic Fluences, London Tower Test, Brixton Anticipation Test, Subtest Similarities and Reasoning for Matrices -WAIS-IV-, Subtest Search for Symbols and Cipher and related calculation of the Processing Speed ¿¿Index -WAIS-IV-, Digit Memory subtest -WAIS-IV-, Symbols Span subtest -WMS-IV-, Logical Memory subtest I-II, Learning of Pairs of Words I-II and Visual Reproduction I-II -WMS-IV-, Attentional Matrices, Stroop Test, Trail Making Test AB) at baseline, at 3 months, at 6 months and after 11 months in all arms of the study (Evaluations Long and Short Intermediate NPS).
    1. il questionario autosomministrato sulla sintomatologia cognitiva soggettivamente percepita (FACT-Cog) alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio;
    2. i test psicometrici (Esame Breve Dello Stato Cognitivo -EBSC-, Frontal Assessment Battery -FAB-, Fluenze Fonemiche, Test delle Torri di Londra, Brixton Anticipation Test, subtest Somiglianze e Ragionamento per Matrici -WAIS-IV-, subtest Ricerca di Simboli e Cifrario e relativo calcolo dell’Indice di Velocità di Elaborazione -WAIS-IV-, subtest Memoria di Cifre -WAIS-IV-, subtest Span di Simboli -WMS-IV-, subtest Memoria Logica I-II, Apprendimento di Coppie di Parole I-II e Riproduzione Visiva I-II -WMS-IV-, Matrici Attenzionali, Test di Stroop, Trail Making Test A-B) alla baseline, a 3 mesi, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio (Valutazioni NPS Lunghe e Brevi Intermedie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. at baseline, at 6 months and after 11 months in all arms of the study;
    2. at baseline, at 3 months, at 6 months and after 11 months in all arms of the study (Evaluations Long and Short Intermediate NPS).
    1. alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio;
    2. alla baseline, a 3 mesi, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio (Valutazioni NPS Lunghe e Brevi Intermedie).
    E.5.2Secondary end point(s)
    Assess the possible effect, and the relative influence, of anxiety and mood tone on cognitive anxiety disorders and mood tone on cognitive disorders through self-administered questionnaires (STAI and HADS); Measure serum brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha levels; Measure any changes in Quality of Life using the self-administered FACT-G and FBSI questionnaires
    Valutare l’eventuale effetto, e la relativa influenza, dell’ansia e del tono dell’umore sui disturbi cognitivi dell’ansia e del tono dell’umore sui disturbi cognitivi tramite questionari autosomministrati (STAI e HADS); II. Misurare i livelli sierici di brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha; Misurare eventuali variazioni nella Qualità di Vita tramite i questionari autosomministrati FACT-G e FBSI
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the base-line; At the base-line and 6 months after enrollment and start of therapy; At baseline, at 6 months and after 11 months in all arms of the study using the self-administered FACT-G and FBSI questionnaires;
    Basale; Alla base-line e a 6 mesi dall’arruolamento e inizio della terapia; Alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio tramite i questionari autosomministrati FACT-G e FBSI;
    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) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Riabilitazione Cognitiva e Consigli Nutrizionali
    Cognitive rehabilitation and nutritional advice.
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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 Information not present in EudraCT
    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
    Overall, the conclusion of the study is set for the 30th month from the start of the project (3 November 2022).
    Complessivamente la conclusione dello studio è fissata al 30° mese dall’inizio del progetto (3 Novembre 2022).
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 320
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state320
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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)
    Not defined
    Non definiti
    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 Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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