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    Summary
    EudraCT Number:2010-022897-14
    Sponsor's Protocol Code Number:preMENAC-2011-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-04
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2010-022897-14
    A.3Full title of the trial
    A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study examining a combination of treatments (exercise, diet advice and anti-inflammatory medication) in the treatment of weight loss, fatigue and poor appetite in cancer
    A.3.2Name or abbreviated title of the trial where available
    Pre-MENAC Study
    A.4.1Sponsor's protocol code numberpreMENAC-2011-01
    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 SponsorGreater Glasgow Health Board
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeatson West of Scotland Cancer Centre
    B.5.2Functional name of contact pointLiz-Anne Lewsley
    B.5.3 Address:
    B.5.3.1Street AddressClinical Trials Unit, Level 0, 1053 Great Western Road
    B.5.3.2Town/ cityGLASGOW
    B.5.3.3Post codeG12 0YN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01413017193
    B.5.5Fax number01413017244
    B.5.6E-mailliz-anne.lewsley@glasgow.ac.uk
    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 celecoxib
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecelecoxib
    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 INNcelecoxib
    D.3.9.1CAS number 194044-54-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-operable stage III/IV non-small cell lung cancer
    Pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    Inoperable cancer of the lung and pancreas
    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 LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025052
    E.1.2Term Lung cancer non-small cell stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is a multimodal intervention for cancer cacheixa feasible?

    Specific indiviudal treatments such as exercise, nutritional advice, dietary supplements and anti-inflammatory medications have been shown to be beneficial in isolation in the treatment of cancer cachexia. It is hypothesized that combining all of these as a "multimodal intervention" may be beneficial. Before a definitive study is conducted to assess this, it is important that the feasibility of delivering such an intervention is assessed - which is the purpose of the proposed study.

    The feasibility will be assessed by:
    •Enrolment rate
    •Compliance with study intervention, study procedures and data collection
    •Contamination-rate in the control group with respect to any of the interventions in the intervention group
    •Provide an estimate of the sample size required in futures studies in cachexia
    E.2.2Secondary objectives of the trial
    •Can the intervention stabilise or improve skeletal muscle mass?
    •Can the intervention improve or stabilize physical function?
    •Can the intervention improve or stabilize nutrition?
    •Can the intervention reduce fatigue?
    •Does the intervention improve overall survival?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of non operable non-small cell lung cancer (NSCLC) (stage III-IV) or pancreatic cancer
    2. Due to commence chemotherapy or chemoradiotherapy
    3. Have a staging CT within 4 weeks of commencement of chemotherapy or chemoradiotherapy
    4. All baseline assessments can be completed within 2 weeks prior to first cycle of chemotherapy or chemoradiotherapy
    5. 18–75 years of age
    6. A life expectancy of ≥4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement)
    7. Karnofsky Performance Score ≥ 70
    8. Written informed consent
    9. Able to provide a blood sample
    E.4Principal exclusion criteria
    1. Neuro-endocrine pancreatic cancer
    2. Renal impairment(serumalbumin < 25 g/L eller Child-Pugh ≥10), creatinine clearance <30ml/min (estimated using cockcroft-gault, creatinine measured within two months of date of consent)
    3. Receiving parenteral nutrition or enteral nutrition via feeding tube
    4. Weight loss >20% over the previous 6 months
    5. BMI >30 kg/m2
    6. Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements)
    7. Use of appetite stimulants (such as megestrol acetate, progestational agents, growth hormone, dronabinol, marijuana or other anabolic agent) within 30 days prior to study baseline
    8. Concomitant long term steroid treatment (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted).
    9. Concomitant long term NSAID or Aspirin treatment.
    10. Regularly scheduled on kinase inhibitors (e.g. sorafinib)
    11. Women during pregnancy, breastfeeding or who are in child-bearing age and do not use adequate contraception
    12. Positive history of heart disease, i.e., severe (New York Heart Association Functional class III or IV) heart failure, uncontrolled hypertension (diastolic blood pressure >95 mmHg at screening), history of previous myocardial infarction, unstable angina, coronary revascularization, uncontrolled arrhythmia, and cerebrovascular accident
    13. Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration
    14. History of bronchospasm, asthma, rhinitis, nasal polyps, angioneurotic oedema or urticaria with intake of NSAID or aspirin therapy
    15. History of hyper sensibility related to intake of acetylsalisylsyre or NSAIDs, including COX-2 (cyklooksygenase-2) inhibitors.
    16. History of hyper sensibility to Sulphonamides
    17. Ongoing/planned radiotherapy during the study period affecting the gastric/oesophagus area
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility of recruitment and retention for the study.
    E.5.2Secondary end point(s)
    - Objective measure of lean body mass
    - Assessment of physical function
    - Assessment of nutritional status
    - Assessment of fatigue
    - Death
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 3, week 6, week 9 and week 12.
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Standard cancer care
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    For the purposes of the CTA the end of the trial is defined as 30 days after the last patient follow up. For the purposes of ethics, the study end date is deemed to be the date of the last data capture.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Once the study has been completed (12 weeks), patients can still undertake exercise and nutritional components of the study should they wish.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-15
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