Non-operable stage III/IV non-small cell lung cancer Pancreatic cancer MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Orga
Conditions
Interventions
Trade Name: celecoxib
Product Name: celecoxib
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: celecoxib
CAS Number: 194044-54-7
Sponsors
Greater Glasgow Health Board
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 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Neuro-endocrine pancreatic cancer 2. Renal impairment(serumalbumin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ; Secondary Objective: •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? ;Primary end point(s): Feasibility of recruitment and retention for the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objective measure of lean body mass - Assessment of physical function - Assessment of nutritional status - Assessment of fatigue - Death ;Timepoint(s) of evaluation of this end point: Baseline, week 3, week 6, week 9 and week 12. | — |
Countries
Denmark, Norway, United Kingdom
Contacts
Public ContactLiz-Anne Lewsley
Beatson West of Scotland Cancer Centre
Outcome results
None listed