- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568316
Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients
Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uskudar
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Istanbul, Uskudar, Turkey, 34668
- Sağlık Bilimleri University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Preoperative Immunonutrition (Group 1)
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 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. |
Experimental: Experimental: Perioperative Immunonutrition (Group 2)
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional Status
Time Frame: At the beginning of the study (7 days before the operation)
|
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.
|
At the beginning of the study (7 days before the operation)
|
Anthropometric Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Height in meters was measured by researchers at the begining of the study.
|
At the beginning of the study (7 days before the operation)
|
Anthropometric Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Body weight in kilogram was measured by researchers.
|
At the beginning of the study (7 days before the operation)
|
Anthropometric Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Weight and height will be combined to report BMI in kg/m^2
|
At the beginning of the study (7 days before the operation)
|
Anthropometric Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Albumin levels in g/dL of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Biochemical Measurements
Time Frame: At the beginning of the study (7 days before the operation)
|
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
|
At the beginning of the study (7 days before the operation)
|
Anthropometric Measurements
Time Frame: 7th day after the operation
|
Body weight in kilogram was measured by researchers.
|
7th day after the operation
|
Anthropometric Measurements
Time Frame: 7th day after the operation
|
Weight and height will be combined to report BMI in kg/m^2
|
7th day after the operation
|
Anthropometric Measurements
Time Frame: 7th day after the operation
|
Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
Albumin levels in g/dL of participants was recorded from hospital's patients form.
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: On the operation day (Day 0)
|
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
|
On the operation day (Day 0)
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
Albumin levels in g/dL of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Biochemical Measurements
Time Frame: 7th day after the operation
|
C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.
|
7th day after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications of Participants
Time Frame: After the operation, up to 30 days.
|
Infections (such as urinary tract, wound infections) and complications were recorded during the postoperative period.
|
After the operation, up to 30 days.
|
Lenght of Hospital Stay of Participants
Time Frame: After the operation, up to 30 days.
|
The length of patients' hospital stay were recorded during the postoperative period.
|
After the operation, up to 30 days.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/151-2879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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