Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134440
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-07
Brief Title:
ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
ImmunoNutrition and Colorectal Adenocarcinoma Surgery a Randomized Study INCAS Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCAS
Brief 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 ERAS 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 Nestle Health Science Spa 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
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 ERAS 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 Nestle Health Science Spa 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None