Updated protocol and guest participant results from the ACCeRT clinical study

Introduction: Cancer cachexia is a condition often seen at diagnosis, throughout chemotherapeutic treatments and in end stage Non-Small Cell Lung Cancer patients. These patients often experience a shorter life-expectancy and deterioration in performance status and reduced quality of life. New multi˗targeted regimens are required to be tested in this population to address these issues. Materials and methods: The ACCeRT study is an open label, prospective, randomised controlled feasibility study investigating the use of eicosapentaenoic acid and COX-2 inhibitor (celecoxib) versus eicosapentaenoic acid, COX-2 inhibitor (celecoxib), progressive resistance training followed by ingestion of essential amino acids high in leucine in Non-Small Cell Lung Cancer cachectic patients. The study protocol was published in November 2011. Due to study participants and study team preferences a number of changes were made. Firstly, a change from a bolus drink containing 20 g of essential amino acids to an encapsulated form in divided doses over three days. Secondly, a change in leg strength analysis from utilising a leg/back dynamometry to a customised chair with a load cell testing extension isometric force. Thirdly, study drug dose reductions were now permitted. Fourthly, addition of two study sites which allowed participants to attend progressive resistance training sessions in their local area. Finally, a change in inclusion criteria to include participants that had received any first-line anti-cancer treatment. A guest participant was invited onto the study in April 2012, followed by the first study participant in June 2012. Results: The guest participant showed trends in efficacy in a number of outcomes; stable fat free mass in the context of decreasing total body weight, with stable FAACT˗PWB, MFSI-SF physical, and WHOQOL-BREF QOL scores at week 20, all during documented disease progression now termed refractory cachexia. There were no treatment or exercise-related adverse events. Conclusion: Publishing feasibility study protocols allows transparency in study interventions and assessments. The above ACCeRT regimen stabilised fat free mass and a number of physical/performance indicators and QOL in the guest participant.