Clinical trial NCT06128798: Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
Official title: A Randomized Controlled Trial on Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Immunonutrition
Colorectal Cancer
Oral Impact
Lead sponsor: Hospital Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

The main questions it aims to answer are:

1. Does immunonutrition preoperatively facilitate earlier return of Gastrointestinal function?
2. Does immunonutrition significantly reduce risk of post-operative surgical site infections?
3. Does immunonutrition significantly reduce duration of hospital stay in patients undergoing colorectal surgery?

Immunonutrition can be defined as modulation of either the activity of the immune system, or modulation of the consequences of activation of the immune system, by nutrients or specific food items fed in amounts above those normally encountered in the diet.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

Partipicant will be randomised into this two arm and then they will consume the respective arm study material for total of 7 days preoperatively.

Data will be collected in post operative period and will be analysed.

Detailed description: Colorectal cancer (CRC) is the commonest cancer in Malaysian men and the second most common cancer in Malaysian women, accounting for age standardized rate of 14.8 and 11.1 incidences per 100,000 population respectively.

Oncological colonic resection is one of mainstay treatment modality for colorectal tumour. Major surgery precipitate release of stress hormones, inflammatory mediators and metabolic changes resulting in significant catabolic phenomena. This sequentially imposed significant dysfunction of the overall host homeostasis, defence mechanism and inflammatory response. Hence, the major setbacks of colorectal surgery are delay return of normal bowel physiology state, post-operative complications and prolonged hospital stay. This affects patients physiologically and psychologically.

Traditionally , patients undergo major abdominal surgery will be kept nil per oral for 6 to 12 hours prior to operation. Post operatively, parenteral or enteral fluids given until bowel function returns to normal. Fortunately, the introduction of the Enhanced Recovery After Surgery (ERAS) programs in last decade has led to enhanced in the recovery of patients postoperatively. The main aspects of substantial improvements in the care of postoperative patients include early initiation of oral intake as soon as possible, integration of nutrition support ,metabolic control and early mobilisation.

As nutritional status plays a significant role to influence the clinical outcomes, nutrition support has been widely used for elective colorectal surgery patients. Literature reported that nutritional risk rate of cancer patients to be 26% to 76 %, higher than of general patients.

Immunonutrition has been used as therapeutic options for peri-operative nutritional management in patients undergoing surgery. The nutrients of immunonutrition formula usually include arginine, omega-3 fatty acids, glutamine and nucleotides.

The current international guidelines recommend that patient's with high risk of malnutrition should be given immunonutrition in perioperative period prior to major oncologic surgeries.These guidelines are based on randomized controlled trials demonstrating a reduction in the rate of post-operative complications.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings. It comes in sachet form which mixed with water prior to consumption. Multiple randomised controlled trial supported Oral IMPACT as immunonutrition.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

In nutshell , it is important for proper perioperative nutritional support for patients scheduled for colorectal surgery. It remain as major advantage for successful procedure.

In the light of this guideline investigators aimed to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

Eligibility criteria: Inclusion Criteria:

1. Age is at least 18 years old
2. All cases posted for Laparoscopic elective colorectal surgery

Exclusion Criteria:

1. Known allergy to milk, fish, and soy.
2. On fluid restriction
3. Emergency Surgery
4. Minor Age \< 18 years old

Primary outcomes:
measure: Physiology Return of Bowel Function
timeFrame: Through study completion , an average of 1 year
Secondary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days post operative period
measure: Length of Hospital Stay
timeFrame: From date of admission until patient is discharged back home or date of death from any cause during admission , whichever come first ,accessed up to 1 year
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Hospital Universiti Sains Malaysia
name: Siti Rahmah Binti Hashim Isa Merican, Dr
role: STUDY_DIRECTOR
affiliation: Hospital Universiti Sains Malaysia
name: Muhammad Faeid BIn Othman, Dr
role: STUDY_DIRECTOR
affiliation: Hospital Universiti Sains Malaysia
name: Manivaasan Pannirselvam, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universiti Sains Malaysia
name: Nor Syarahani Binti Jusoh, Dr
role: STUDY_DIRECTOR
affiliation: Hospital Universiti Sains Malaysia
name: Wong Pak Kai ( Michael), Dr
role: STUDY_DIRECTOR
References:
citation: Shaikh SR, Jolly CA, Chapkin RS. n-3 Polyunsaturated fatty acids exert immunomodulatory effects on lymphocytes by targeting plasma membrane molecular organization. Mol Aspects Med. 2012 Feb;33(1):46-54. doi: 10.1016/j.mam.2011.10.002. Epub 2011 Oct 19.
citation: Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
citation: Lee SY, Jung MR, Kim CH, Kim YJ, Kim HR. Nutritional risk screening score is an independent predictive factor of anastomotic leakage after rectal cancer surgery. Eur J Clin Nutr. 2018 Apr;72(4):489-495. doi: 10.1038/s41430-018-0112-3. Epub 2018 Feb 19.
citation: Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
citation: Chang HR, Bistrian B. The role of cytokines in the catabolic consequences of infection and injury. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):156-66. doi: 10.1177/0148607198022003156.
citation: Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.
citation: Grimble RF. Basics in clinical nutrition: Immunonutrition - Nutrients which influence immunity: Effect and mechanism of action. Vol. 4, e-SPEN. Elsevier BV; 2009.
citation: Xiong L, Teng JL, Botelho MG, Lo RC, Lau SK, Woo PC. Arginine Metabolism in Bacterial Pathogenesis and Cancer Therapy. Int J Mol Sci. 2016 Mar 11;17(3):363. doi: 10.3390/ijms17030363.
citation: Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
citation: Hess JR, Greenberg NA. The role of nucleotides in the immune and gastrointestinal systems: potential clinical applications. Nutr Clin Pract. 2012 Apr;27(2):281-94. doi: 10.1177/0884533611434933. Epub 2012 Mar 5.
citation: Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
citation: Cruzat V, Macedo Rogero M, Noel Keane K, Curi R, Newsholme P. Glutamine: Metabolism and Immune Function, Supplementation and Clinical Translation. Nutrients. 2018 Oct 23;10(11):1564. doi: 10.3390/nu10111564.