NCT05568316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

April 18, 2023

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 25, 2022

Last Update Submit

April 17, 2023

Conditions

Colorectal Cancer

Keywords

colorectal cancerImmunonutritionNutritional Status

Outcome Measures

Primary Outcomes (26)

  • 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)

  • 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)

  • Anthropometric Measurements

    Body weight in kilogram was measured by researchers.

    At the beginning of the study (7 days before the operation)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Anthropometric Measurements

    Body weight in kilogram was measured by researchers.

    7th day after the operation

  • Anthropometric Measurements

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

    7th day after the operation

  • Anthropometric Measurements

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

    7th day after the operation

  • Biochemical Measurements

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

    On the operation day (Day 0)

  • Biochemical Measurements

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

    On the operation day (Day 0)

  • Biochemical Measurements

    Fasting plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.

    On the operation day (Day 0)

  • Biochemical Measurements

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

    On the operation day (Day 0)

  • Biochemical Measurements

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

    On the operation day (Day 0)

  • Biochemical Measurements

    C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.

    On the operation day (Day 0)

  • Biochemical Measurements

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

    7th day after the operation

  • Biochemical Measurements

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

    7th day after the operation

  • Biochemical Measurements

    Fasting Plasma glucose (FPG) mg/dL in of participants was recorded from hospital's patients form.

    7th day after the operation

  • Biochemical Measurements

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

    7th day after the operation

  • Biochemical Measurements

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

    7th day after the operation

  • Biochemical Measurements

    C-reactive protein (CRP) in mg/L of participants was recorded from hospital's patients form.

    7th day after the operation

Secondary Outcomes (2)

  • Postoperative Complications of Participants

    After the operation, up to 30 days.

  • Lenght of Hospital Stay of Participants

    After the operation, up to 30 days.

Study Arms (2)

Experimental: Preoperative Immunonutrition (Group 1)

EXPERIMENTAL

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.

Dietary Supplement: Preoperative Immunonutrition

Experimental: Perioperative Immunonutrition (Group 2)

EXPERIMENTAL

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.

Dietary Supplement: Perioperative Immunonutrition

Interventions

Preoperative ImmunonutritionDIETARY_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.

Experimental: Preoperative Immunonutrition (Group 1)
Perioperative ImmunonutritionDIETARY_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.

Experimental: Perioperative Immunonutrition (Group 2)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with colorectal cancer,
  • from 18 years up to 65 years old,
  • To be volunteer,
  • Informed written consent

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 30923785BACKGROUND

  • 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.

    PMID: 31384599BACKGROUND

  • 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.

    PMID: 27081153BACKGROUND

  • 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.

    PMID: 27227930BACKGROUND

  • 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.

    PMID: 27637832BACKGROUND

  • Ural B, Yilmaz-Akyuz E, Akyuz C. Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Clinical Trial. Nutr Cancer. 2024;76(6):469-475. doi: 10.1080/01635581.2024.2338607. Epub 2024 Apr 13.

    PMID: 38613322DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • BEDRİYE URAL, Dr

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

  • Elvan YILMAZ AKYUZ, Assoc. Prof.

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

  • Cebrail AKYUZ, Assoc. Prof.

    Haydarpasa Numune Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

October 5, 2022

Study Start

November 1, 2020

Primary Completion

October 30, 2021

Study Completion

February 10, 2022

Last Updated

April 18, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)