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Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

Clinical Trial Summary

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck

Clinical Trial Description

In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04611113
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact Riccardo Caccialanza, MD
Phone 0382501615
Email r.caccialanza@smatteo.pv.it
Status Recruiting
Phase N/A
Start date March 17, 2021
Completion date November 15, 2022
View Details
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