ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

Colorectal Adenocarcinoma Clinical Trial

— INCAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134440
• Other study ID #: IOV-CRC-01-2022 INCAS
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Istituto Oncologico Veneto IRCCS
• Contact: Boris Franzato
• Phone: 0423421306
• Email: boris.franzato[@]iov.veneto.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma

Intervention

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 Nestle´ 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.

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto IRCCS	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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	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	Secondary Outcome Measure - Unplanned readmissions	Unplanned readmissions within 30 days from discharge	within 30 days from discharge
Secondary	Secondary Outcome Measure - 30-day mortality for any cause	30-day mortality for any cause	30-day mortality for any cause
Secondary	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	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	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