"Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition versus Standard Enteral Nutrition in Elective Upper Digestive Cancer Surgery."
On the occasion of the SENPE (Spanish Society of Clinical Nutrition and Metabolism) congress, which was held on May 31, June 1 and 2, 2019 in the city of Santiago de Compostela, Adventia Pharma has collaborated by financing a scholarship to the best research project on the impact of a formula with immunomodulatory nutrients.
The jury, made up of the SENPE Scientific Educational Committee (CCE) and a member of the SENPE Board of Directors, have awarded the ADVENTIA PHARMA scholarship to the project entitled: “Randomized multicenter clinical trial of the effect of preoperative immunonutrition versus standard enteral nutrition in elective upper digestive tract cancer surgery ". This is a multicenter study, whose main researchers are Dr. Miguel Ángel Martínez Olmos and Dr. Alfonso Vidal Casariego, and will include the work of researchers from both Endocrinology and Nutrition Services of the Santiago University Hospital Complex (CHUS) and of the University Hospital Complex of A Coruña (CHUAC).
Dr. Rocío Villar Taibo, Specialist in Endocrinology and Nutrition at the Complejo Hospitalario Universitario de Santiago, brings us a little closer to the research project.
- What is the study you are going to carry out?
It is a randomized, double-blind, multicenter clinical trial that will evaluate the results of immunonutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach and pancreas). The objective is to compare the specific effect of immunonutrients with respect to an equivalent formula in caloric-protein intake but without immunonutrients. The study will be carried out in the health areas of Santiago de Compostela and A Coruña, has the approval of the Galicia Research Ethics Committee and will begin in the coming weeks.
- How important is immunomodulatory nutritional support in patients with cancer of the esophagus, stomach and pancreas?
Immunonutrition in this context aims to modulate the inflammatory response and improve the immune response in the perioperative period. In this way, we want to improve the clinical evolution of cancer patients in terms of reducing postoperative morbidity and hospital stay.
- What novelties can this study represent, at the immunonutrition level, with respect to those already existing in the scientific literature and at a practical level?
Several studies have demonstrated the benefits of immunonutrition, laying the foundations for the recommendation of perioperative immunonutrition in upper digestive neoplasms in international guidelines (ESPEN and ASPEN). But not all studies have found the same benefits, in fact we can find discordant results in the literature. Probably the lack of homogeneity in the immunonutrition formulas used, in the doses of immunonutrients, the treatment time or the route of administration used, as well as insufficient sample sizes or the lack of randomization and blinding of the studies, can explain the disparity of results found and the difficulty in comparing different studies. Our study aims to shed light on this issue, evaluating the usefulness of a specific immunonutrition regimen, with a formula with a sufficient and adequate supply of immunonutrients. In addition, the one that includes exclusive polyphenols from extra virgin olive oil (EVOO) is totally new, since the formulas traditionally used in immunonutrition studies did not incorporate them.
- What benefits can the patient expect who receives an immunomodulatory formula with arginine, omega 3, nucleotides, antioxidants and exclusive polyphenols from EVOO?
What we seek with the contribution of immunonutrients is to reduce infectious and non-infectious complications after surgical intervention in patients with esophageal, gastric or pancreatic cancer and reduce their hospital stay. We hope that the added effect of the polyphenols in EVOO, in terms of its anti-inflammatory, antioxidant and even anti-tumor action, represents a point of difference with respect to other existing studies in the literature.
- What future lines of research could this study entail?
On the one hand, it would be interesting to investigate the effect of these formulas on the clinical evolution of other groups of patients (such as patients with head and neck cancer or some critical patients). However, we would also like to continue delving into other aspects such as changes in body composition, in lymphocyte populations or in the oxidation-reduction state of the organism with immunonutrition, as well as epigenetics.
- What does it mean for you to be able to count on this SENPE scholarship sponsored by Adventia?
I would like to emphasize that this is a team project, in which I am just one of the members. Colleagues from the Endocrinology and Nutrition Services of the Complejo Hospitalario Universitario de Santiago and the Complejo Hospitalario Universitario de A Coruña have come together to design and launch this exciting project and the scholarship we have achieved will make it possible to carry it out. We hope that the scientific evidence resulting from this work can be useful for our daily clinical practice and can be extrapolated to other healthcare settings and on behalf of the entire team we thank Adventia Pharma for its commitment to research and its support.