Status:
RECRUITING
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
Lead Sponsor:
Istituto Oncologico Veneto IRCCS
Conditions:
Colorectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Th...
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 supplement...
Eligibility Criteria
Inclusion
- Patients aged ≥ 18 years or older;
- histologically confirmed adenocarcinoma of colon or rectum;
- Eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique;
- eligible for ERAS protocol;
- Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
Exclusion
- colon or rectal resection for benign disease;
- TNM Stage ≥4;
- neoadjuvant radio and/or chemotherapy
- ASA score \> 3;
- contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product;
- albuminemia \< 3.0 g/l;
- weight loss \> 10% in the last 3-6 months;
- BMI \< 18.5 kg/m2;
- pregnant or breastfeeding;
- Not self-sufficient or with poor family compliance;
- Congenital or acquired immunodeficiency;
- Active uncontrolled pre-operative infections or other clinically relevant concomitant illness that preclude laparoscopic procedure;
- Bowel obstruction or parenteral nutrition or gastric tube;
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06134440
Start Date
November 21 2023
End Date
January 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
Istituto Oncologico Veneto IRCCS
Padua, Italy, 35128