ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study (NCT06134440) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
Timeframe: within 30 days post-surgical intervention