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 |
weight and muscle loss during chemotherapy treatment for cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
Can a combination of nutritional supplements, omega 3 fatty acids, exercise and anti-inflammatory medication prevent or reduce weight loss in patients with pancreatic or lung cancer who are about to start palliative chemotherapy. |
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E.2.2 | Secondary objectives of the trial |
Can a combination of nutritional supplements, omega 3 fatty acids, exercise and anti-inflammatory medication prevent or reduce muscle loss and maintain or increase muscle strength and physical ability in patients with pancreatic or lung cancer who are about to start palliative chemotherapy. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The UK arm of the trial will collect additional blood samples to measure plasma EPA levels at baseline 6 weeks and 12 weeks |
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E.3 | Principal inclusion criteria |
1.Diagnosis of lung cancer or pancreatic cancer 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), or pancreatic adenocarcinoma (stage III or IV), due to commence first or second line anticancer treatment (defined as chemotherapy or chemo-radiotherapy,immunotherapy 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 8. ≥ 18 years of age |
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E.4 | Principal exclusion criteria |
1. Neuro-endocrine pancreatic cancer 2. Creatinine clearance <30ml/min (estimated from serum creatinine and patient age and weight) 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)
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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 |
baseline, 3 weeks, 6 weeks, 12 weeks |
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E.5.2 | Secondary end point(s) |
Muscle mass and Physical activity |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, 3 weeks, 6 weeks, 12 weeks |
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Canada |
Germany |
Ireland |
Norway |
Switzerland |
United Kingdom |
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E.8.7 | Trial 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
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Date of death will be collected for three months after last patient last visit. As this is the last data collection point, three months after last patient last visit will be the end of study date. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 29 |