NCT06134440

ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Nestlé 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.

Conditions

• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Impact Oral®	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 Nestlé 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.

Timeline

• Start date: 2023-11-21
• Primary completion: 2025-09-09
• Completion: 2026-02-25
• First posted: 2023-11-18
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy