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Trial Title:
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
NCT ID:
NCT06134440
Condition:
Colorectal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, controlled, open-label, single-centre study in patients candidate to elective
curative surgery for colon-rectal cancer.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Impact Oral®
Description:
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 group label:
Arm A (interventional arm)
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Boris Franzato
Phone:
0423421306
Phone ext:
+39
Email:
boris.franzato@iov.veneto.it
Contact backup:
Last name:
Andrea Barina
Phone:
0423421306
Phone ext:
+39
Email:
andrea.barina@iov.veneto.it
Investigator:
Last name:
Boris Franzato, MD
Email:
Principal Investigator
Investigator:
Last name:
Andrea Barina, MD
Email:
Sub-Investigator
Start date:
November 21, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Source:
Istituto Oncologico Veneto IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06134440
