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    Summary
    EudraCT Number:2011-002337-19
    Sponsor's Protocol Code Number:STUDIODH-OMEOPATIA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 number2011-002337-19
    A.3Full title of the trial
    A PHASE II EXPLORATIVE STUDY EVALUATING ACTIVITY AND SAFETY OF HOMEOPATHIC MEDICINE ON CANCER RELATED FATIGUE (CRF) AND QUALITY OF LIFE IN ONCOLOGIC PATIENTS UNDER CHEMOTHERAPY IN DAY HOSPITAL AT FIDENZA GENERAL HOSPITAL (PR)- STUDY DH -HOMEOPATHY
    STUDIO ESPLORATIVO DI FASE II SULLA ATTIVITA' E SICUREZZA DELLA MEDICINA OMEOPATICA NELLA RIDUZIONE DELLA ASTENIA ASSOCIATA AL CANCRO (AAC) E SULLA QUALITA' DELLA VITA IN PAZIENTI ONCOLOGICI SOTTOPOSTI A CHEMIOTERAPIA SEGUITI DAL DAY HOSPITAL DI FIDENZA (PR) - STUDIO DH-OMEOPATIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PILOT, PHASE II, MONOCENTRIC STUDY WITHOUT A CONTROL GROUP, ON ACTIVITY AND SAFETY OF HOMEOPATIC MEDICINE ON CANCER RELATED FATIGUE (CRF) AND QUALITY OF LIFE IN PATIENTS UNDER CHEMOTHERAPY
    STUDIO PILOTA, , MONOCENTRICO, SENZA GRUPPO DI CONTROLLO, DI FASE II RIGUARDANTE L’ATTIVITA' E LA SICUREZZA DELLA MEDICINA OMEOPATICA SU ASTENIA ASSOCIATA AL CANCRO (AAC) E QUALITA' DELLA VITA, IN PAZIENTI SOTTOPOSTI A CHEMIOTERAPIA.
    A.3.2Name or abbreviated title of the trial where available
    STUDY DH-HOMEOPATHY
    STUDIO DH-OMEOPATIA
    A.4.1Sponsor's protocol code numberSTUDIODH-OMEOPATIA
    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 UNITA' SANITARIA LOCALE DI PARMA
    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 Emilia Romagna
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportCEMON s.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComitato Etico Unico per la provincia di Parma
    B.5.2Functional name of contact pointSegreteria Scientifica
    B.5.3 Address:
    B.5.3.1Street Addressvia Gramsci 14
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number0521704775
    B.5.5Fax number0521704702
    B.5.6E-mailgideluca@ao.pr.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 No
    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
    D.3.2Product code NA
    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.3.8INN - Proposed INNPHOSPHORUS
    D.3.9.1CAS number 7723-14-0
    D.3.10 Strength
    D.3.10.1Concentration unit pg picogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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
    Oncologic patients
    Malati oncologici
    E.1.1.1Medical condition in easily understood language
    Oncologic patients
    Malati oncologici
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the main aim is to explore the activity of the homeopathic remedy on cancer related fatigue (CRF), the most common side effect of cancer treatment, not always well controlled by conventional therapies. The symptom is checked by the BFI questionnaire, internationally validated. The aim therefore is to reach an adequate proportion of success justifying a controlled phase III study on more specific cancer patients.
    L’obiettivo principale è quello di osservare l’attività del rimedio omeopatico con un tipico studio di fase II sull’astenia associata al cancro (AAC); sintomo ad alta prevalenza non sempre risolto dai trattamenti convenzionali (che continueranno ad essere prescritti ai soggetti in studio), misurato con il questionario BFI, validato a livello internazionale. L’obiettivo è dunque quello di raggiungere un grado di risposta al trattamento (secondo il metodo in due stadi di Simon) che giustifichi l’avvio di una sperimentazione controllata su di un gruppo omogeneo di pazienti oncologici. Non esistono evidenze di effetti avversi legati all’assunzione di medicinali omeopatici, nè in corso di sperimentazione nè in corso di sorveglianza sull’uso; è stata tuttavia prediposta una scheda di raccolta dati per la segnalazione.
    E.2.2Secondary objectives of the trial
    It is interesting to explore the variation of the quality of life in patients under chemotherapy. Also we describe the sample features and provide a monitoring of the clinical parameters together with homeopathic methodology, paying particular attention to remedies used for one type of tumour, homeopathic dilution and homeopathic reactions to the remedy.
    Si ritiene utile esplorare anche le eventuali modifiche sulla qualità di vita del paziente in trattamento chemioterapico, monitorare i parametri clinici, Saranno descritte le caratteristiche del campione e le variabili legate alla metodologia omeopatica, con particolare riguardo a rimedi usati per tipo di tumore, diluizioni omeopatiche.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects of male and female gender, 18 years older, under chemotherapy: 1) adjuvant and with no relapse of illness 2) with metastatic progressive illness after a first line chemotherapy and have to begin or are under a second or third line chemotherapy Ø patients with CRF that have a score of almost 4 in item 2 of BFI questionnaire, measured at baseline. Ø Subjects treated for malignancy of tumours, both solid and haematological, with EORTC supplementary module available. Ø Subjects able to sign the informed consent and to complete the questionnaires independently.
    Soggetti di ambo i sessi e di età superiore a 18 anni in trattamento chemioterapico: 1) adiuvante e che non presentano segni di ripresa di malattia 2) con malattia metastatica in progressione dopo un trattamento di prima linea e che devono iniziare o hanno iniziato una seconda o terza linea. Ø pazienti sofferenti del sintomo AAC con punteggio uguale o superiore a 4 nel l’item 2 del questionario BFI, misurato alla baseline Ø Pazienti affetti da tutti i tipi di tumore maligno solido o ematologico per i quali sia disponibile il questionario EORTC specifico validato o in fase di completamento (fase III) Ø Soggetti in grado di leggere il foglio informativo, firmare il consenso informato e compilare autonomamente i questionari
    E.4Principal exclusion criteria
    - Subjects with anemia (Hb < 9 g/dl, HT < 30%), reduction of Hb =/> 2 g/dl in the preceding month - Subjects with co-morbidities, evaluated during the first oncologic visit , that could be associated to fatigue: 1) hypothyroidism not controlled by therapy 2) insomnia 3) diabetes with HBA1C values lower than 9% in the last control 4) anxiety under therapy by not more than two months or with continous adjusting dose 5) subject in anticipation of radiotherapy or surgery 6) hypertension not controlled with drugs 7) acute or chronic respiratory insufficiency 8) women in pregnancy or breast-feeding - subjects included in other studies of conventional or not conventional medicine -Variation in BFI score greater than 1 point, between the three measures or the first and the third one, performed before the baseline
    Ø presenza di un’oscillazione del punteggio del BFI tra le tre misure o una differenza tra BFI post-1° ciclo e BFI post-3° ciclo maggiore a 1 per l’item 3.

    Ø Soggetti sofferenti di anemia con Hb &lt; 9 g/dl, HT &lt; 30, riduzione dell’Hb =/&gt; 2 g/dl nel mese precedente

    Ø Soggetti con significativa comorbidità, valutata al momento della prima visita oncologica , potenzialmente associata alla presenza di astenia:

    o ipotiroidismo non controllato dalla terapia sostitutiva
    o insonnia persistente
    o diabete con valori di HBA1C inferiori a 9% nell’ultimo accertamento
    o disturbo ansioso in terapia ansiolitica da meno di 2 mesi o con dosaggio non ancora stabilizzato
    o soggetto in programma per radioterapia o intervento chirurgico
    o ipertensione arteriosa non controllata da farmaci
    o insufficienza respiratoria acuta o cronica grave
    o donne in gravidanza o in allattamento

    Ø Soggetti già inseriti in sperimentazioni in corso, sia riguardanti medicine convenzionali che non convenzionali
    E.5 End points
    E.5.1Primary end point(s)
    We misure the scoring of the items 2, 3 and the mean of the scoring of 4a-4f items of BFI questionnaire, completed at the baseline, 1 week after the third chemotherapy cycle, and successively 1 week after every chemotherapy cycle preceding the 2°-3° and 3°-4° medical examinations, as well as following the 4°.
    L’outcome primario è misurato dal punteggio degli item 2, 3 e dalla media dei punteggi degli item 4a-4f del questionario BFI, compilato alla baseline (1° settimana dopo il terzo ciclo di chemioterapia) e 1° settimana dopo il ciclo di chemioterapia che precede la 2°-3° e la 3°-4° visita omeopatica e che segue la 4°.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18-19 months
    18-19 mesi
    E.5.2Secondary end point(s)
    BFI questionnaire: compare the mean scores at baseline ant at every next step, using repeated measures analysis of variance or non parametric test. EORTC questionaire: mean difference between the baseline-last measure scoring for each EORT-C30 and Supplementary module scale for each cancer.
    Questionario BFI: confronto tra le medie dei punteggi raccolti alla baseline e ad ogni step successivo, mediante analisi della varianza per misure ripetute sullo stesso soggetto, o test equivalente nel caso di applicabilità di statistica non parametrica; Questionario EORTC: differenza tra la media del punteggio delle due misurazioni (baseline-termine), per ogni scala dell’EORT-C30 e dei questionari tumore specifici.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18-19 months
    18-19 mesi
    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 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 Yes
    E.6.13.1Other scope of the trial description
    PHASE II STUDY ABOUT ACTIVITY
    STUDIO DI FASE II, DI ATTIVITA'
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cecità del paziente
    blinded patients
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    FOLLOWING STANDARD CHEMOTHERAPY PROTOCOLS
    PROSECUZIONE DEI PROTOCOLLI CHEMIOTERAPICI STANDARD
    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 Decision2011-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-13
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