Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer
Conditions
Interventions
Trade Name: Celebra
Product Name: Celebra
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CELECOXIB
CAS Number: 169590-42-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Dep. of Cancer Research and Molecular medicine, Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Renal impairment, creatinin clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: This is a feasibility trial and all endpoints are related to compliance to the intervention and all over feasibility of the trial. ;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 Reaso | — |
Countries
Denmark, Norway, United Kingdom
Outcome results
None listed