Effect of omega-3 supplementation on the nutritional status of patients with pancreatic cancer: A protocol for systematic review of clinical trials

Abstract

Background: Globally, pancreatic cancer is the seventh most common cause of cancer-related death in both sexes, accounting for 466,003 deaths and 495,773 new cases in 2020. The purpose of this study was to synthesize and evaluate evidence on the effects of omega-3 supplementation on the nutritional status of patients with pancreatic cancer. Methods: This systematic review protocol will be guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Five databases will be searched: MEDLINE/PubMed, CENTRAL Cochrane, EMBASE, Web of Science, and SCOPUS, with no restrictions on the publication date nor language. The internal validity and risk of bias of randomized controlled trials will be assessed using the revised Cochrane Risk-Of-Bias tool for randomized trials (RoB 2), whereas the risk of bias in non-randomized studies of interventions will be evaluated using the ROBINS-I. The heterogeneity among the studies will be assessed using the I2 statistic. Based on the results of this test, we will verify whether the meta-analysis would be feasible. If feasibility would be confirmed, a random-effect model analysis will be performed. For data analysis, the calculation of the pooled effect estimates will have a 95% confidence interval, while the alpha will be set to 0.05 using the R statistical software version 4.0.4. All methodological steps of this review will be performed independently by two reviewers and will be conducted and managed in the EPPI-Reviewer Software™. Results: This review may be of particular interest to researchers and clinicians, given the low survival and overall burden of patients with pancreatic cancer. Furthermore, the results of this systematic review may contribute to the development of new nutritional interventions in these patients. Conclusion: To the best of our knowledge, this will be the first study to critically assess the scientific evidence and estimate the effect of omega-3 supplementation on the nutritional status of patients with pancreatic cancer. The review will perform a rigorous approach, adhering to the PRISMA Statement 2020 using a comprehensive and systematic search strategy in five databases and additional sources with no time period nor language restrictions.