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    Summary
    EudraCT Number:2013-002282-19
    Sponsor's Protocol Code Number:MENAC-2013-05
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-07-19
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-002282-19
    A.3Full title of the trial
    The MENAC Trial
    A randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) plus standard care versus standard care alone to prevent / attenuate cachexia in advanced cancer patients undergoing chemotherapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intervention investigating the effect of the combination of ibuprofen, oral nutritional supplement(with EPA) and exercise in attenuating cancer cachexia
    A.3.2Name or abbreviated title of the trial where available
    MENAC
    A.4.1Sponsor's protocol code numberMENAC-2013-05
    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 SponsorEuropean Palliative Care Research Centre (PRC), NTNU
    B.1.3.4CountryNorway
    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 supportEuropean Palliative Care Research Centre (PRC), Norwegian University of Science and Technology
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Palliative Care Research Centre (PRC), Norwegian University of Science and Technology
    B.5.2Functional name of contact pointStein Kaasa
    B.5.3 Address:
    B.5.3.1Street AddressPostboks 8905
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7491
    B.5.3.4CountryNorway
    B.5.4Telephone number+4791897001
    B.5.6E-mailstein.kaasa@ntnu.no
    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 Ibuprofen ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameIbuprofen
    D.3.2Product code M01AE01
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.2Current sponsor codeNTNU
    D.3.9.3Other descriptive nameNSAID
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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
    Unintentional weight loss , cachexia, increases chemotherapy toxicity and reduces survival and quality of life. There is no treatment available today. Based on knowledge of cachexia pathophysiology and previous single intervention studies, we now investigate in a RCT trial if multimodal cachexia intervention(nutritional therapy with EPA, physical exercise and anti-inflammatory treatment(ibuprofen))+standard treatment improves weight and physical performance better than standard treatment alone.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced cancer and cachexia
    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
    Body weight – difference between intervention and control group at
    study endpoint (T2)
    E.2.2Secondary objectives of the trial
    All endpoints will be assessed at T2 between the two groups
    Muscle Mass: difference using CT L3 technique
    Physical activity: difference in step count assessed by ActivPAL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation
    2. Patients with non-small cell lung cancer (stage III or IV), small cell lung cancer (extensive stage) or pancreatic adenocarcinoma (stage III or IV) or non-operable cholangiocarcinoma, due to commence first or second line anticancer treatment (defined as chemotherapy or chemo-radiotherapy or targeted therapy
    3. Have a staging CT within 4 weeks of commencement of anti-cancer therapy (in patients where staging CT is out-with this period, further CT scanning will be undertaken. PET-CT’s are also appropriate)
    4. Have completed all other baseline assessments within one week prior to first course of anti-cancer treatment
    5. Provide written informed consent
    6. Able to comply with trial interventions (in the opinion of referring clinician) e.g. willing and able to do light exercise and take ONS as well as no major contraindications against ibuprofen*.
    7. Karnofsky Performance Status >70

    *The use of proton-pump inhibitor should be decided upon by the physician in charge of the patient if the patient has a history of dyspepsia or gastric ulcer. If the patient has had a recent gastric ulcer the patient is not eligible as she/he has a major contraindication to ibuprofen
    E.4Principal exclusion criteria
    1. Neuro-endocrine pancreatic cancer
    2. Creatinine clearance <30ml/min.**
    3. Receiving parenteral nutrition or enteral nutrition via feeding tube
    4. Patients receiving neo-adjuvant anti-cancer therapy
    5. BMI >30 kg/m2
    6. Use of appetite stimulants or anabolic/anti-catabolic agents (such as megestrol acetate, progestational agents, marijuana growth hormone, dronabinol, or other anabolic agent) within 30 days prior to study baseline
    7. Concomitant steroid (>10mg/d prednisolone or equivalent) treatment for less than three months prior to inclusion (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted)
    8. Concomitant long term (>1 week) NSAID or Aspirin treatment***
    9. Women during pregnancy, breast-feeding or who are of child bearing potential (that is not postmenopausal or permanently sterilised) age and who do not use adequate contraception (oral, injected, implanted or hormonal methods of contraception, intrauterine device and barrier method)
    10. Concomitant anti-coagulant treatment (e.g. warfarin or heparin)

    ** Patients who are receiving pemetrexed and have mild to moderate renal insufficiency (Creatinine Clearance 45-79 ml/min) should not take ibuprofen for 2 days before, on the day of and 2 days after pemetrexed administration.

    *** Patients who are taking aspirin, NSAID or Cox 2 inhibitors prior to study entry can participate in the study providing these medications are either permanently or temporarily stopped during trial participation. This should only be done following discussion with the clinician responsible for the patient’s general care – usually general practitioner or family physician. In patients who are taking other medication which may interact with ibuprofen, e.g. fluconazole, the risks/benefits of these medications should be considered and discussed with the study physician, prior to patient recruitment.

    E.5 End points
    E.5.1Primary end point(s)
    Body weight will be used as the primary end point in the MENAC trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (T0), Midpoint week 3 (T1), Endpoint week 6 (T2)
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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) 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 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
    Patients in the control group receive standard care
    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
    Patients in the control group receive standard care
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    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
    For the purposes of Clinical Trial Authorization the trial is deemed to have ended 30 days after follow-up however date of death will be recorded where applicable. The trial will continue for 3 months after the last patient has completed to ensure censoring is kept to a minimum. For the purposes of the ethics, the study end date is deemed to be the date of the last data capture. The sponsor can also terminate the study for safety reasons.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 240
    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)
    Patients should preferably continue with the excercise and nutrition intervention
    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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-01
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