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.
Solheim, T. S., Laird, B. J. A., Balstad, T. R., Stene, G. B., Bye, A., Johns, N., Pettersen, C. H., Fallon, M., Fayers, P., Fearon, K. C. H., & Kaasa, S. (2017). A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. Journal of Cachexia, Sarcopenia and Muscle, 8(5), 778-788. https://doi.org/10.1002/jcsm.12201