A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer

BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical func-tion. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim ofthis study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritionalsupplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung orpancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia inter-vention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance withintervention (>50% of components in>50% of patients). Key secondary outcomes were change in weight, muscle mass, phys-ical activity, safety, and survival.ResultsThree hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twentyfive patients wererandomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the indi-vidual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As ex-pected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were nointervention-related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer;however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effectof the intervention.