Clinical trial NCT05568316: Impact of Immunonutrition on Nutritional Status in Colorectal Cancer Patients
Official title: Impact of Immunonutrition on Nutritional Status in Patients Undergoing Colorectal Cancer Surgery: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
Immunonutrition
Nutritional Status
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Haydarpasa Numune Training and Research Hospital
First posted: 2022-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Nutritional Status
timeFrame: At the beginning of the study (7 days before the operation)
measure: Anthropometric Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Anthropometric Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Anthropometric Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Anthropometric Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Biochemical Measurements
timeFrame: At the beginning of the study (7 days before the operation)
measure: Anthropometric Measurements
timeFrame: 7th day after the operation
measure: Anthropometric Measurements
timeFrame: 7th day after the operation
measure: Anthropometric Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: On the operation day (Day 0)
measure: Biochemical Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: 7th day after the operation
measure: Biochemical Measurements
timeFrame: 7th day after the operation
Secondary outcomes:
measure: Postoperative Complications of Participants
timeFrame: After the operation, up to 30 days.
measure: Lenght of Hospital Stay of Participants
timeFrame: After the operation, up to 30 days.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri University
state: Uskudar
Study officials:
affiliation: Sağlık Bilimleri University
name: BEDRİYE URAL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Sağlık Bilimleri University
name: Elvan YILMAZ AKYUZ, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haydarpasa Numune Research and Training Hospital
name: Cebrail AKYUZ, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.