E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer
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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 |
The overall objectives are the feasibility of patient recruitment, compliance to the multimodal intervention as well as the assessment of possible contamination of the control group. This will be assessed by: • Patient recruitment • Compliance to the intervention and attrition • Compliance with the data collection procedures • Contamination of the control group
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E.2.2 | Secondary objectives of the trial |
This is a feasibility trial and all endpoints are related to compliance to the intervention and all over feasibility of the trial. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer 2. Due to commence systematic chemotherapy or combination chemo-radiotherapy. 3. Have a staging CT within 3 weeks of commencement of systemic chemotherapy/chemo-radiotherapy at study baseline 4. 18–75 years of age 5. A life expectancy of ≥4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement) 6. Karnofsky Performance Score ≥ 70 7. Written informed consent 8. Able to provide a blood sample
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E.4 | Principal exclusion criteria |
1. Renal impairment, creatinin clearance <30ml/min (estimated using cockroft-gault, creatinine measured within two months of date of consent) 2. Receiving parenteral nutrition or enteral nutrition via feeding tube 3. Weight loss >20% over the previous 6 months 4. BMI >30 kg/m2 5. Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements) 6. Stated taking appetite stimulants such as megestrol acetate, progestational agents, steroids, growth hormone, dronabinol, marijuana or other anabolic agents 7. Concomitant long term steroid treatment (inhaled, optical steroids or pulsed dexamethasone is permitted) 8. Concomitant long term NSAID or Aspirin treatment. 9. Regularly scheduled on kinase inhibitors (e.g. sorafinib) 10. Women of child-bearing age who not using adequate contraception 11. 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 12. Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration 13. History of bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy 14. Ongoing/planned radiotherapy during the study period affecting the gastric/oesophagus area
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Feasibility of Recruitment
This is assessed by: • The number/percentage of potentially eligible patients • The number/percentage of patients accepting to participate to the study • The number/percentage of patients who start the study protocol • Where are the patients recruited from? • Who do we recruit into the study? What characterize the participants? • Are the eligibility criteria feasible?
2. Compliance to the Intervention
This is assessed by:
• Nutrition: Data on dietary intake using the 24 h recall method Nutrition -10-point verbal analogue scale (AveS) for dietary intake Daily log for the compliance of oral nutritional supplement (ONS) Serum values of eicosapentaenoic acid (EPA) will be measured as a biomarker of compliance with the intake of the ONS
• Anti-inflammatory medication: The remaining pills will be counted at week 3 and 6 during the intervention and registered by a study investigator (by phone or e-mail)
• Physical exercise Daily completed exercise sessions/daily walks is registered in an activity calendar and returned to the study nurse at 3 and 6 weeks
• Registration of number of adverse events
• The number/percentage of patients who drop out at various stages of the study and reasons for drop out
3. Compliance with the Data Collection Procedures
This is assessed by:
• Patient Reported Outcomes – o Completion rates (%) or number of missing items in questionnaires. o Reasons for withdrawal or missing data • Objective measures of physical- performance and activity o Completion rates (%) or missing data in physical testing – reasons for withdrawal or missing data o ActivPAL - missing data (removal of sensor, loss of data, technical difficulties, patient discomfort – reasons for withdrawal or missing data o Biomarkers o No. of blood/urine sample collected o Reports of technical difficulties
4. Contamination of the Control Group
This is assessed by: • Serum values of eicosapentaenoic acid (EPA) will be measured as a biomarker of contamination of the control group at baseline and at end of study • Data on dietary intake using the 24 h recall method and Nutrition -10-point verbal analogue scale (AveS) for dietary intake will also provide information about change in dietary intake
• Registration on the use of NSAIDs in the control group (medications last 24 hours)
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | 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 | 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 | Yes |
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 |
Control group (standard care) |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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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For the purposes of Clinical Trial Authorisation the trial is deemed to have ended 30 days after follow-up. For the purposes of the ethics, the study end date is deemed to be the date of the last data capture.
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |