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ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study — INCAS  

Colorectal Adenocarcinoma Clinical Trial

Official title:
ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study

Clinical Trial Summary

Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.

Clinical Trial Description

Randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer. The study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to E.R.A.S. protocol. All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by NestleĢ Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06134440
Study type Interventional
Source Istituto Oncologico Veneto IRCCS
Contact Boris Franzato
Phone 0423421306
Email boris.franzato@iov.veneto.it
Status Recruiting
Phase N/A
Start date November 21, 2023
Completion date September 2025
View Details
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