TerminatedNot Applicable

ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

Stopped: problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.

Italy71 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications

Timeframe: within 30 days post-surgical intervention

Trial details

NCT IDNCT06134440

SponsorIstituto Oncologico Veneto IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-09