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Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Preoperative Immunonutrition
Perioperative Immunonutrition
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer, Immunonutrition, Nutritional Status

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with colorectal cancer,
  • 18 years or older,
  • To be volunteer,
  • Informed written consent

Exclusion Criteria:

  • Under the age of 18,
  • To be pregnant,
  • Acute and chronic renal failure, cirrhosis, advanced COPD, mechanical intestinal obstruction, metastasis, presence of sepsis,
  • The ejection fraction is below 35%.

Sites / Locations

  • Sağlık Bilimleri University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: Preoperative Immunonutrition (Group 1)

Experimental: Perioperative Immunonutrition (Group 2)

Arm Description

Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for only 5 days before surgery, in addition to their standard isocaloric diet. Duration: 5 days (preoperative) Dietary therapy: Standard oral nutrition and IMN product for 5 days before operation. The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded.

Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet. Duration: 5 days preoperative and 5 days postoperative Dietary therapy: Standard oral nutrition and IMN product for 5 days before and after operation (perioperative). The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded.

Outcomes

Primary Outcome Measures

Nutritional Status
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Score >3: The patient is at risk for nutrition and a nutrition facility is started Score <3: one should be scanned. If there is a major operation plan, a nutrition plan should also be developed.
Anthropometric Measurements
Height in meters was measured by researchers at the begining of the study.
Anthropometric Measurements
Body weight in kilogram was measured by researchers.
Anthropometric Measurements
Weight and height will be combined to report BMI in kg/m^2
Anthropometric Measurements
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Anthropometric Measurements
Body weight in kilogram was measured by researchers.
Anthropometric Measurements
Weight and height will be combined to report BMI in kg/m^2
Anthropometric Measurements
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Biochemical Measurements
Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Biochemical Measurements
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Biochemical Measurements
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.

Secondary Outcome Measures

Postoperative Complications of Participants
Infections (such as urinary tract, wound infections) and complications were recorded during the postoperative period.
Lenght of Hospital Stay of Participants
The length of patients' hospital stay were recorded during the postoperative period.

Full Information

First Posted
August 25, 2022
Last Updated
April 17, 2023
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Haydarpasa Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05568316
Brief Title
Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients
Official Title
Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Haydarpasa Numune Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal cancer is among the top three types of cancer that are most common and causes death worldwide.Nutritional support is widely used in elective colorectal surgery patients, as nutritional status is an important factor affecting clinical outcomes. European Society for Clinical Nutrition and Metabolism (ESPEN, 2016) emphasizes that nutritional supplementation with compounds such as amino acids, arginine, glutamine, and fish oil (omega 3) improves postoperative recovery. Glutamine; it becomes an essential amino acid under stress. It is an energy substrate for cells such as intestinal mucosal cells and lymphocytes, a material for glutathione synthesis, and a potent antioxidant, which also increases heat shock protein expression. In stressful conditions, arginine is the primary fuel source for T cells and is required for nitric oxide synthesis; therefore, it helps maintain immune function. Omega 3; It plays a role in the treatment of inflammation and improves wound healing. In addition, EPA and DHA increase the immune response by improving lymphocyte function. RNA; They are essential for maturation, proliferation, and function in nearly all biochemical processes, in rapidly proliferating cells such as T cells. studies have shown that immunonutrition (IMN) formulas enriched with biologically active compounds may be more effective in reducing infection complications and shortening postoperative hospital stays. This study aimed to investigate the additional effects of perioperative compared with preoperative immunonutrition on anthropometric, nutritional, and biochemical parameters, complications, and the length of hospital stay in patients with colorectal cancer.
Detailed Description
Colorectal cancer is one of the five most common cancer types in men and women worldwide. Cancer malnutrition is seen in patients with colorectal cancer, and this adversely affects the prognosis of the disease. Major operations performed may lead to dysfunction in body homeostasis, impaired defense mechanisms and inflammatory response, increasing the risk of postoperative complications and prolonging hospital stay. Nutritional support products enriched with special compounds such as arginine, glutamine, and omega3 may contribute to the daily energy intake of patients, as well as support the immune system, increase wound healing, and reduce the risk of infection. It is well-documented that preoperative and perioperative compared to no immunonutrition effectively reduce the risk of developing infectious complications and the length of hospital stay. Unless, studies on this subject are very few, especially in our country, Turkey, and their results are contradictory. The aim of this study is to investigate the additional effects of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer. The hypotheses of this study are as follows: H0: There is no difference between the consumption of perioperative compared with preoperative immunonutrition (IMN) on anthropometric, nutritional, biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer. H1: Perioperative immunonutrition compare to preoperative has a positive effect in improving the anthropometric measurements, nutritional and biochemical parameters, hospital stay and postoperative complication in patients with colorectal cancer. Primary purpose: To evaluate the effects of IMN on anthropometric measurements, nutritional and biochemical values of participants in groups. Secondary purpose: To evaluate the effects of IMN on postoperative complications and length of hospital stay in groups. The study was conducted as a single-blind prospective randomized controlled clinical trial at a single institution, Haydarpasa Numune Training and Research Hospital General Surgery Clinic, Istanbul, Turkey, between November 2020 and October 2021. The participants included consecutive patients undergoing colorectal cancer surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, Immunonutrition, Nutritional Status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Preoperative Immunonutrition (Group 1)
Arm Type
Experimental
Arm Description
Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for only 5 days before surgery, in addition to their standard isocaloric diet. Duration: 5 days (preoperative) Dietary therapy: Standard oral nutrition and IMN product for 5 days before operation. The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded.
Arm Title
Experimental: Perioperative Immunonutrition (Group 2)
Arm Type
Experimental
Arm Description
Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet. Duration: 5 days preoperative and 5 days postoperative Dietary therapy: Standard oral nutrition and IMN product for 5 days before and after operation (perioperative). The nutritional status of the patients was determined from the NRS 2002 screening tool. The biochemical parameters (albumin, prealbumin, CRP, FPG etc.), anthropometric measurements (body weight, BMI, MUAC), postoperative complications and hospital stay were recorded.
Intervention Type
Dietary Supplement
Intervention Name(s)
Preoperative Immunonutrition
Intervention Description
Participants consumed oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before surgery. The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Perioperative Immunonutrition
Intervention Description
Participants received oral IMN supplementation containing arginine, omega-3 fatty acids, and dietary nucleotides for 5 days before and after surgery, in addition to their standard isocaloric diet. The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Anthropometric measurements (height, body weight, BMI, and middle-upper arm circumference) were measured at the beginning (7 days before the operation) and seventh day after the operation. The biochemical parameters (albumin, prealbumin, C-reactive protein, fasting plasma glucose, alanine aminotransferase, and aspartate aminotransferase) of participants were recorded 7 days before, on the day, and 7 days after the operation from hospital patients forms.Infections (such as urinary tract, wound infections), complications, and the length of patients' hospital stay were recorded during the postoperative period.
Primary Outcome Measure Information:
Title
Nutritional Status
Description
The nutritional status of patients was evaluated according to the score determined from the NRS 2002 screening tool. Score >3: The patient is at risk for nutrition and a nutrition facility is started Score <3: one should be scanned. If there is a major operation plan, a nutrition plan should also be developed.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Anthropometric Measurements
Description
Height in meters was measured by researchers at the begining of the study.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Anthropometric Measurements
Description
Body weight in kilogram was measured by researchers.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Anthropometric Measurements
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
At the beginning of the study (7 days before the operation)
Title
Anthropometric Measurements
Description
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Biochemical Measurements
Description
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Time Frame
At the beginning of the study (7 days before the operation)
Title
Anthropometric Measurements
Description
Body weight in kilogram was measured by researchers.
Time Frame
7th day after the operation
Title
Anthropometric Measurements
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
7th day after the operation
Title
Anthropometric Measurements
Description
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Time Frame
On the operation day (Day 0)
Title
Biochemical Measurements
Description
Albumin levels in g/dL of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Title
Biochemical Measurements
Description
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
Time Frame
7th day after the operation
Secondary Outcome Measure Information:
Title
Postoperative Complications of Participants
Description
Infections (such as urinary tract, wound infections) and complications were recorded during the postoperative period.
Time Frame
After the operation, up to 30 days.
Title
Lenght of Hospital Stay of Participants
Description
The length of patients' hospital stay were recorded during the postoperative period.
Time Frame
After the operation, up to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with colorectal cancer, from 18 years up to 65 years old, To be volunteer, Informed written consent Exclusion Criteria: Under the age of 18, Above the age of 65 To be pregnant, Acute and chronic renal failure, cirrhosis, advanced COPD, mechanical intestinal obstruction, metastasis, presence of sepsis, The ejection fraction is below 35%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BEDRİYE URAL, Dr
Organizational Affiliation
Sağlık Bilimleri University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elvan YILMAZ AKYUZ, Assoc. Prof.
Organizational Affiliation
Sağlık Bilimleri University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cebrail AKYUZ, Assoc. Prof.
Organizational Affiliation
Haydarpasa Numune Research and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sağlık Bilimleri University
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30923785
Citation
Fukatsu K. Role of nutrition in gastroenterological surgery. Ann Gastroenterol Surg. 2019 Feb 25;3(2):160-168. doi: 10.1002/ags3.12237. eCollection 2019 Mar.
Results Reference
background
PubMed Identifier
31384599
Citation
Karimian J, Hadi A, Salehi-Sahlabadi A, Kafeshani M. The Effect of Arginine Intake on Colorectal Cancer: a Systematic Review of Literatures. Clin Nutr Res. 2019 Jul 25;8(3):209-218. doi: 10.7762/cnr.2019.8.3.209. eCollection 2019 Jul.
Results Reference
background
PubMed Identifier
27081153
Citation
Bharadwaj S, Trivax B, Tandon P, Alkam B, Hanouneh I, Steiger E. Should perioperative immunonutrition for elective surgery be the current standard of care? Gastroenterol Rep (Oxf). 2016 May;4(2):87-95. doi: 10.1093/gastro/gow008. Epub 2016 Apr 14.
Results Reference
background
PubMed Identifier
27227930
Citation
Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
Results Reference
background
PubMed Identifier
27637832
Citation
Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
Results Reference
background

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Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients

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