ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study (INCAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Adenocarcinoma
• Intervention / Treatment: Dietary supplement: Impact Oral®

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris Franzato; Phone Number: +39 0423421306; Email: boris.franzato@iov.veneto.it
• Study Contact Backup: Name: Andrea Barina; Phone Number: +39 0423 421306; Email: andrea.barina@iov.veneto.it

Study Locations

• Italy
  • Padova, Italy, 35128
    • Recruiting
    • Istituto Oncologico Veneto IRCCS
    • Contact: Boris Franzato; Phone Number: +39 0423421306; Email: boris.franzato@iov.veneto.it
    • Contact: Andrea Barina; Phone Number: +39 0423421306; Email: andrea.barina@iov.veneto.it
    • Principal Investigator: Boris Franzato, MD
    • Sub-Investigator: Andrea Barina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (interventional arm); 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®; 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.
No Intervention: Arm B (control arm); a low fiber dietary advice only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure - Hospital length of stay	Hospital length of stay defined as hospitalization from the day of surgery until discharge	From the day of surgery until discharge, assessed up to 7 days
Secondary Outcome Measure - Reoperation rate	Reoperation rate within 30 days from index surgery defined as any unplanned post-operative procedure including a return in the operating room or an imaging-guided intervention within 30 days following the index surgery	within 30 days following the index surgery
Secondary Outcome Measure - Unplanned readmissions	Unplanned readmissions within 30 days from discharge	within 30 days from discharge
Secondary Outcome Measure - 30-day mortality for any cause	30-day mortality for any cause	30-day mortality for any cause
Secondary Outcome Measure - Safety assessed according to CTCAE	Safety assessed according to criteria to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5	From admission to discharge, assessed up to 42 days
Secondary Outcome Measure - Nutritional status before and after surgery	Nutritional status before and after surgery will be assessed evaluating albumin, prealbumin and transferrin serum levels: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms	differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms
Secondary Outcome Measure - Inflammatory status before and after surgery	Inflammatory status before and after surgery will be assessed evaluating leukocytes (x10^(9)/L), C-reactive protein (PCR) (mg/dL), procalcitonin (ug/L), neutrophil-lymphocyte (ratio), and lactate dehydrogenase (LDH) serum levels (U/L). The haematic quantification of this biomarkers provides information about the inflammatory status.	differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Translational Outcome Measures - Evaluation of the immune-modulatory effects of OIN in the tumor micro-environment in CRC patients	To evaluate the immune-modulatory effects of OIN in the tumor micro-environment in CRC patients. Immunological assessment of adaptive and innate immune cells will be investigated on pre-operative biopsy and surgical specimen by immunohistochemistry (IHC), and pre and post-treatment on peripheral blood by flow cytometry.	The analysis will be performed 7 days before surgery and 5 days after surgery.

Collaborators and Investigators

• Sponsor: Istituto Oncologico Veneto IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: IOV-CRC-01-2022 INCAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No