Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568316
• Other study ID #: 2020/151-2879
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: August 2022
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 10, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Preoperative Immunonutrition
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.
• Perioperative Immunonutrition
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri University	Istanbul	Uskudar

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the beginning of the study (7 days before the operation)
Primary	Anthropometric Measurements	Height in meters was measured by researchers at the begining of the study.	At the beginning of the study (7 days before the operation)
Primary	Anthropometric Measurements	Body weight in kilogram was measured by researchers.	At the beginning of the study (7 days before the operation)
Primary	Anthropometric Measurements	Weight and height will be combined to report BMI in kg/m^2	At the beginning of the study (7 days before the operation)
Primary	Anthropometric Measurements	Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.	At the beginning of the study (7 days before the operation)
Primary	Biochemical Measurements	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)
Primary	Biochemical Measurements	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)
Primary	Biochemical Measurements	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)
Primary	Biochemical Measurements	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)
Primary	Biochemical Measurements	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)
Primary	Biochemical Measurements	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)
Primary	Anthropometric Measurements	Body weight in kilogram was measured by researchers.	7th day after the operation
Primary	Anthropometric Measurements	Weight and height will be combined to report BMI in kg/m^2	7th day after the operation
Primary	Anthropometric Measurements	Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.	7th day after the operation
Primary	Biochemical Measurements	Albumin levels in g/dL of participants was recorded from hospital's patients form.	On the operation day (Day 0)
Primary	Biochemical Measurements	Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.	On the operation day (Day 0)
Primary	Biochemical Measurements	Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.	On the operation day (Day 0)
Primary	Biochemical Measurements	Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.	On the operation day (Day 0)
Primary	Biochemical Measurements	Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's	On the operation day (Day 0)
Primary	Biochemical Measurements	C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.	On the operation day (Day 0)
Primary	Biochemical Measurements	Albumin levels in g/dL of participants was recorded from hospital's patients form.	7th day after the operation
Primary	Biochemical Measurements	Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.	7th day after the operation
Primary	Biochemical Measurements	Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.	7th day after the operation
Primary	Biochemical Measurements	Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.	7th day after the operation
Primary	Biochemical Measurements	Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.	7th day after the operation
Primary	Biochemical Measurements	C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.	7th day after the operation
Secondary	Postoperative Complications of Participants	Infections (such as urinary tract, wound infections) and complications were recorded during the postoperative period.	After the operation, up to 30 days.
Secondary	Lenght of Hospital Stay of Participants	The length of patients' hospital stay were recorded during the postoperative period.	After the operation, up to 30 days.