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NCT Number: NCT05568316

Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Preoperative immunonutrition

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. 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.

  2. 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.

  3. Anthropometric Measurements

    Time frame: At the beginning of the study (7 days before the operation)

    Body weight in kilogram was measured by researchers.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Anthropometric Measurements

    Time frame: 7th day after the operation

    Body weight in kilogram was measured by researchers.

  13. Anthropometric Measurements

    Time frame: 7th day after the operation

    Weight and height will be combined to report BMI in kg/m^2

  14. Anthropometric Measurements

    Time frame: 7th day after the operation

    Middle-upper arm circumference (MUAC) in centimeter was measured by using tape measure.

  15. Biochemical Measurements

    Time frame: On the operation day (Day 0)

    Albumin levels in g/dL of participants was recorded from hospital's patients form.

  16. Biochemical Measurements

    Time frame: On the operation day (Day 0)

    Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.

  17. 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.

  18. 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.

  19. Biochemical Measurements

    Time frame: On the operation day (Day 0)

    Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's

  20. 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.

  21. Biochemical Measurements

    Time frame: 7th day after the operation

    Albumin levels in g/dL of participants was recorded from hospital's patients form.

  22. Biochemical Measurements

    Time frame: 7th day after the operation

    Prealbumin levels in mg/dL of participants was recorded from hospital's patients form.

  23. 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.

  24. Biochemical Measurements

    Time frame: 7th day after the operation

    Alanine aminotransferase (ALT) in IU/L of participants was recorded from hospital's patients form.

  25. Biochemical Measurements

    Time frame: 7th day after the operation

    Aspartate aminotransferase (AST) in IU/L of participants was recorded from hospital's patients form.

  26. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Haydarpasa Numune Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 5, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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