Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

a low-fiber dietary advice + oral nutritional supplement enriched with immune-nutrients for 5 pre-operative days and 5 post-operative days.

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.

Impact Oral®

Boris Franzato

Andrea Barina

Boris Franzato, MD

Andrea Barina, MD

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.

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.

Randomized, controlled, open-label, single-centre study in patients candidate to elective curative surgery for colon-rectal cancer.

ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study

ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study

To evaluate the immune-modulatory effects of OIN in the tumor micro-environment in CRC patients. Immunological assessment of adaptive and innate immune cells will be investigated on pre-operative biopsy and surgical specimen by immunohistochemistry (IHC), and pre and post-treatment on peripheral blood by flow cytometry.

Number of patients with grade 2 or higher post-operative complications according to Clavien-Dindo classification occurred within 30 days post-surgical intervention.

Hospital length of stay defined as hospitalization from the day of surgery until discharge

Reoperation rate within 30 days from index surgery defined as any unplanned post-operative procedure including a return in the operating room or an imaging-guided intervention within 30 days following the index surgery

Unplanned readmissions within 30 days from discharge

Safety assessed according to criteria to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5

Nutritional status before and after surgery will be assessed evaluating albumin, prealbumin and transferrin serum levels: differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms

Inflammatory status before and after surgery will be assessed evaluating leukocytes (x10\^(9)/L), C-reactive protein (PCR) (mg/dL), procalcitonin (ug/L), neutrophil-lymphocyte (ratio), and lactate dehydrogenase (LDH) serum levels (U/L).

The haematic quantification of this biomarkers provides information about the inflammatory status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study	NCT06134440	Colorectal Aden...	Impact Oral®	18 Years -	Istituto Oncologico Veneto IRCCS
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study	NCT06134440	Colorectal Aden...	Impact Oral®	18 Years -	Istituto Oncologico Veneto IRCCS
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study	NCT06134440	Colorectal Aden...	Impact Oral®	18 Years -	Istituto Oncologico Veneto IRCCS

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