A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study - Pre-MENAC Study

Greater Glasgow Health Board0 sites46 target enrollmentOctober 4, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2011

End Date

September 1, 2014

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Greater Glasgow Health Board

•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

•1\.Neuro\-endocrine pancreatic cancer
•2\.Renal impairment(serumalbumin \< 25 g/L eller Child\-Pugh \=10\), creatinine clearance \<30ml/min (estimated using cockcroft\-gault, creatinine measured within two months of date of consent)
•3\.Receiving parenteral nutrition or enteral nutrition via feeding tube
•4\.Weight loss \>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)