ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

NCT06134440 | Terminated

• 1 other identifier: IOV-CRC-01-2022 INCAS
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications

  Number of patients with grade 2 or higher post-operative complications according to Clavien-Dindo classification occurred within 30 days post-surgical intervention.

  within 30 days post-surgical intervention

Secondary Outcomes (7)

• Secondary Outcome Measure - Hospital length of stay

  From the day of surgery until discharge, assessed up to 7 days

• Secondary Outcome Measure - Reoperation rate

  within 30 days following the index surgery

• Secondary Outcome Measure - Unplanned readmissions

  within 30 days from discharge

• Secondary Outcome Measure - 30-day mortality for any cause

  30-day mortality for any cause

• Secondary Outcome Measure - Safety assessed according to CTCAE

  From admission to discharge, assessed up to 42 days

Other Outcomes (1)

• Translational Outcome Measures - Evaluation of the immune-modulatory effects of OIN in the tumor micro-environment in CRC patients

  The analysis will be performed 7 days before surgery and 5 days after surgery.

Study Arms (2)

Arm A (interventional arm)

EXPERIMENTAL

a low-fiber dietary advice + oral nutritional supplement enriched with immune-nutrients for 5 pre-operative days and 5 post-operative days.

Dietary Supplement: Impact Oral®

Arm B (control arm)

NO INTERVENTION

a low fiber dietary advice only

Interventions

Impact Oral® DIETARY_SUPPLEMENT

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.

Arm A (interventional arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, open-label, single-centre study in patients candidate to elective curative surgery for colon-rectal cancer.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: November 21, 2023
• Primary Completion: September 9, 2025
• Study Completion: February 25, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)