Clinical trial NCT06134440: ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
Official title: ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Adenocarcinoma
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open-label, single-centre study in patients candidate to elective curative surgery for colon-rectal cancer.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
timeFrame: within 30 days post-surgical intervention
Secondary outcomes:
measure: Secondary Outcome Measure - Hospital length of stay
timeFrame: From the day of surgery until discharge, assessed up to 7 days
measure: Secondary Outcome Measure - Reoperation rate
timeFrame: within 30 days following the index surgery
measure: Secondary Outcome Measure - Unplanned readmissions
timeFrame: within 30 days from discharge
measure: Secondary Outcome Measure - 30-day mortality for any cause
timeFrame: 30-day mortality for any cause
measure: Secondary Outcome Measure - Safety assessed according to CTCAE
timeFrame: From admission to discharge, assessed up to 42 days
measure: Secondary Outcome Measure - Nutritional status before and after surgery
timeFrame: 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
measure: Secondary Outcome Measure - Inflammatory status before and after surgery
timeFrame: 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 outcomes:
measure: Translational Outcome Measures - Evaluation of the immune-modulatory effects of OIN in the tumor micro-environment in CRC patients
timeFrame: The analysis will be performed 7 days before surgery and 5 days after surgery.
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
Study officials:
References: