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    Summary
    EudraCT Number:2019-001982-34
    Sponsor's Protocol Code Number:MOVES
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-10
    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 ConcernedFinland - Fimea
    A.2EudraCT number2019-001982-34
    A.3Full title of the trial
    Measuring Oncogical Value of Exercise and Statin
    Syöpäpotilaan ennusteen parantaminen muuttamalla syövän mikroympäristöä ja me-taboliaa liikunnalla ja lääkkeellisesti
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measuring Oncogical Value of Exercise and Statin
    Syöpäpotilaan ennusteen parantaminen liikunnalla ja lääkkeellisesti
    A.4.1Sponsor's protocol code numberMOVES
    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 SponsorPirkanmaan hyvinvointialue
    B.1.3.4CountryFinland
    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 supportSuomen akatemia
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportGrants from different non-commercial sources
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPirkanmaan sairaanhoitopiiri
    B.5.2Functional name of contact pointTeemu Murtola
    B.5.3 Address:
    B.5.3.1Street AddressElämänaukio 2
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33520
    B.5.3.4CountryFinland
    B.5.6E-mailteemu.murtola@pshp.fi
    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 Atorvastatin 40 mg, saatavuuden mukaan kauppanimeä voidaan joutua vaihtamaan tutkimuksen kuluessa.
    D.2.1.1.2Name of the Marketing Authorisation holderVoi vaihdella
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Tablet
    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 INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic breast, ovarian, kidney and prostate cancer
    Levinnyt rinta-, munasarja-, munuais- ja eturauhassyöpä
    E.1.1.1Medical condition in easily understood language
    Metastatic breast, ovarian, kidney and prostate cancer
    Levinnyt rinta-, munasarja-, munuais- ja eturauhassyöpä
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10023404
    E.1.2Term Kidney cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10023405
    E.1.2Term Kidney cancer stage IV
    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
    Main objective is to investigate if supervised group exercise will improve response to cancer treatments in metastasized breast, kidney, prostate, and ovarian cancer compared to unsupervised exercise and also evaluate if atorvastatin treatment in combination with guided group exercise can promote even better treatment responses than exercise alone.
    Parantaako syöpälääkehoidon aikana toteutettu aerobista- ja voimaharjoittelua sisältävä ohjattu ryhmäliikuntaharjoittelu syöpälääkehoidon tehoa levinneessä rintasyövässä, munuaissyövässä, munasarjasyövässä ja eturauhassyövässä omatoimiseen liikuntaan verrattuna ja parantaako ohjattuun ryhmäliikuntaharjoitteluun yhdistetty atorvastatiinin käyttö edelleen syöpähoidon vastetta.
    E.2.2Secondary objectives of the trial
    Impact of exercise, cancer treatment, and side-effects on quality of life, depression symptoms, and relationship
    Kartoittaa potilaan kokemuksia syöpälääkehoidon, niiden sivuvaikutusten ja liikunnan lisäämisen vaikutuksista potilaan kokemaansa elämänlaatuun, depressio-oireisiin ja parisuhteeseen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PET/CT imaging for a sub-group of patients. Objective is to evaluate amount of hypoxia in tumors.
    PET/TT kuvaus alaryhmälle. Tavoitteena kuvata hyposian määrää ja laajuutta kasvaimissa
    E.3Principal inclusion criteria
    1) Histologically and imaging confirmed metastatic breast, ovarian, kidney or prostate cancer in which first line treatment is given
    2) Signed consent
    1) Potilaalla on histologisesti ja kuvantamalla varmennettu etäpesäkkeinen eturauhassyöpä, rintasyöpä, munasarjasyöpä tai munuaissyöpä, johon aloitetaan 1. linjan syöpälääkehoito
    2) Potilas on suostuvainen tutkimukseen ja allekirjoittaa kirjallisen tietoisen suostumuksensa
    E.4Principal exclusion criteria
    1. High risk for bone fracture
    2. Inability for physical exercise and/or inability for cancer treatments
    3. Poor co-operation for psychological reason
    4. Current use of cholesterol-lowering drugs
    5. Severe liver or renal impairment
    6. Previous side-effect of cholesterol-lowering medication
    7. Current use of drugs with known interact with atorvastatin
    1. Korkea luunmurtumien riski
    2. Kyvyttömyys fyysiseen rasitukseen ja/tai soveltumattomuus syöpälääkehoitoon
    3. Huono ko-operaatiokyky psyykkisistä syistä
    4. Aktiivinen kolesterolia alentavien lääkkeiden käyttö
    5. Maksan tai munuaisten vaikea vajaatoiminta
    6. Aiemmin ilmenneet hankalat sivuvaikutukset kolesterolilääkityksen aikana
    7. Atorvastatiinin kanssa yhteisvaikutuksia omaavien lääkeaineiden jatkuva käyttö tutkimusaikana
    E.5 End points
    E.5.1Primary end point(s)
    Cancer progression despite of treatment or death
    Syövän eteneminen hoidosta huolimatta tai kuolema
    E.5.1.1Timepoint(s) of evaluation of this end point
    FU visits every 3 month during 2 years
    Seurantakäynnit 3 kuukauden välein 2 vuoden ajan
    E.5.2Secondary end point(s)
    1. Serum levels of hypoxia markers VEGF, canonic anhydrase IX, LADH, amd HIF1a
    2. Side-effects of treatments
    3. Body consumption before and after intervention
    4. Performance status before and after intervention
    5. Amount of hypoxia in tumors based on PET/CT imaging
    6. Quality of life, depression symptoms, and relationship
    1. Hypoksiamarkkerit – VEGF, Hiilihappoanhydaari IX, LADH ja HIF1α määritykset seerumista
    2. Hoidon siedettävyys
    3. Kehon koostumusmittaus ennen ja jälkeen intervention
    4. Potilaiden suorituskyky (tuoliltanousutesti) ennen ja jälkeen intervention
    5. PET kuvauksilla määritetty hypoksian määrä kasvaimissa
    6. Elämänlaatu, depressio-oireet ja parisuhde
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up visits in 3 months interval for 2 years
    Seurantakäynnit 3 kuukauden välein 2 vuoden ajan
    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 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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 No
    E.8.2.3Other No
    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
    Trial ends after last patient's last follow-up visit
    Tutkimus loppuu kun viimeinen potilas on käynyt viimeisellä seurantakäynnillä
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state240
    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
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Tampere University
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Aalto University
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Helsinki
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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