Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Preoperative Immunonutrition; Perioperative Immunonutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: colorectal cancer; Immunonutrition; Nutritional Status