ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
NCT ID: NCT06134440
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-11-21
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Arm B (control arm)
a low fiber dietary advice only
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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Istituto Oncologico Veneto IRCCS
OTHER
Responsible Party
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Locations
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Istituto Oncologico Veneto IRCCS
Padua, , Italy
Countries
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Central Contacts
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Facility Contacts
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Boris Franzato
Role: primary
Andrea Barina
Role: backup
Other Identifiers
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IOV-CRC-01-2022 INCAS
Identifier Type: -
Identifier Source: org_study_id