cachexia
Conditions
Interventions
Trade Name: Ibuprofen
Product Name: ibuprofen
Pharmaceutical Form: Tablet
INN or Proposed INN: Ibuprofen
CAS Number: 15687-27-1
Sponsors
Norwegian University of Science and technology
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Neuro-endocrine pancreatic cancer 2. Creatinine clearance 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Body Weight;Timepoint(s) of evaluation of this end point: baseline, 3 weeks, 6 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Muscle mass and Physical activity;Timepoint(s) of evaluation of this end point: baseline, 3 weeks, 6 weeks, 12 weeks | — |
Countries
Brazil, Canada, Germany, Ireland, Norway, Switzerland, United Kingdom
Contacts
Public ContactNatalie Hutchings
Southampton Clinical Trials Unit
Outcome results
None listed