Nutritional support for patients undergoing surgery for colorectal cancer
ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study
This study is testing if a special nutritional supplement can help patients with colorectal cancer recover better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova) |
| Trial ID | NCT06134440 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral nutritional supplementation enriched with immune-nutrients on patients undergoing elective curative surgery for colorectal adenocarcinoma. It is a randomized, controlled, open-label trial conducted at a single center, where participants will receive standard dietary advice along with the nutritional supplement before and after surgery. The aim is to assess whether this intervention can improve post-operative outcomes and enhance immune response within the tumor microenvironment. All patients will follow a low-fiber diet as per the Enhanced Recovery After Surgery (ERAS) protocol during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed adenocarcinoma of the colon or rectum who are eligible for elective curative surgery.
Not a fit: Patients with advanced cancer (TNM Stage ≥4), significant weight loss, or contraindications to oral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced complications for patients undergoing surgery for colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with nutritional interventions in malnourished patients undergoing surgery for gastrointestinal cancers, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Padova
- Istituto Oncologico Veneto IRCCS — Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Boris Franzato
- Email: boris.franzato@iov.veneto.it
- Phone: 0423421306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.