E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025044 |
E.1.2 | Term | Lung cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Vi ønsker at undersøge en intervention mod cancer kakeksi hos patienter med inoperabel c.pulm st.III-IV og patienter med c.pancreas. Denne består af - to energidrikke dagl. - tbl. celecoxib - fysisk træning Patienterne randomiseres til to grupper, hvor begge modtager den alm. behandling i onk. afdeling. Den ene halvdel randomiseres derudover til ovenstående intervention i i alt seks uger, parallelt med den onk. behandling. Den anden halvdel er kontrolgruppe, men vil derefter også få tilbudt interventionen. De primære mål med studiet er at estimere - inkl.hastigheden ved dette design og denne patientgruppe - kompliance ift. interventionen, studieprocedurer og dataindsamling - kontaminationsraten i kontrolgruppen ift. interventionen i interventionsgruppen - det nødvendige sample size i et fremtidigt kakeksistudie. Derudover ønsker vi at få belyst brugbarheden af de almindelige outcome measures i kakeksistudier (lean body mass, fysisk funktion, ernæringstilstand, fatique, OS). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Lung cancer
Have a staging CT within 4 weeks of commencement of chemotherapy or chemoradiotherapy (in patients where staging CT is outwith this period, further CT scanning will be undertaken. PET‐CTs are also appropriate)
18–75years of age
about to start chemotherapy |
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E.4 | Principal exclusion criteria |
Renal impairment (serum albumin < 25 g/L or Child‐Pugh ≥10 (pancreatic cancer patients only)), creatinine clearance <30ml/min (estimated using cockroft‐gault, creatinine measured within two months of date of consent)
Patients who are taking either aspirin, NSAID or Cox 2 inhibitors prior to study entry
Women during pregnancy, breastfeeding or who are of child‐bearing potential (that is not postmenopausal or permanently sterilised) age and who do not use adequate contraception (oral, injected or implanted or hormonal methods of contraception’s, intrauterine device and barrier method) |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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end of follow up for last pt |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |