Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery

Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.

Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery.

The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications. However, the evidence comparing between immune formula and standard formula is still controversial. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery.

A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling. Anthropometry and biochemical parameters were measured in 3 periods (before intervention, two weeks after intervention in preoperative, and post-operative period). Postoperative complications were recorded until patient discharge from hospital for 30 days.

Study Overview

• Status: Completed
• Conditions: Cancer; Malnutrition
• Intervention / Treatment: Dietary supplement: Oral Nutrition supplement

Detailed Description

Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery.

The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications especially in malnourished patients undergoing major abdominal surgery. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery.

A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling.

Body mass index (BMI), body composition, mid-arm muscle circumference (MAMC), hand grip strength, food intake, pre-albumin, C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor necrosis factor alpha (TNF-alpha) are measured at the day before and the day after having all of oral nutrition supplements. Parameters are re-measured within 5-7 days after operation along with fasting blood sugar, insulin and HOMAR-IR. Postoperative complications are assessed with Clavien-Dindo classification on the last day in the hospital. Re-admit rates are recorded until 30 days after discharge.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Department of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who were malnourished gastrointestinal cancer patients and plan to treatment with surgery
• Participant aged ≥18 years

Exclusion Criteria:

• Participants who weren't willing to participate in a clinical trial.
• Participants who were pregnant or lactating
• Participants who were enteral feeding intolerance such as gastrointestinal obstruction
• Participants who receive jejunal feeding
• Participant has been taking an immune formula prior to the baseline visit.
• Participants who were allergic to components of the study formula such as milk,soy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling	Dietary supplement: Oral Nutrition supplement; Participants received normal diet and in the interventional group received package of immune formula 2 meals per day for 10-14 days prior surgery.; Other Names: Immune formula
No Intervention: Control group; Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein	C-reactive protein in mg/L	Baseline,Study day 10-14, After surgery day 5-7
Change in Tumor necrosis factor alpha (TNF-α)	Tumor necrosis factor alpha in pg/ml	Baseline,Study day 10-14, After surgery day 5-7
Change in interleukin-6 (IL-6)	Interleukin-6 in pg/ml	Baseline,Study day 10-14, After surgery day 5-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Prealbumin	Prealbumin in (g/L)	Baseline,Study day 10-14, After surgery day 5-7
Mid-upper arm circumference	MAMC in cm	Baseline,Study day 10-14, After surgery day 5-7
BIA	BIA is body composition analysis in muscle mass, fat mass,% body fat	Baseline,Study day 10-14, After surgery day 5-7
Handgrip strength	Handgrip strength in kg	Baseline,Study day 10-14, After surgery day 5-7
Complication during hospitalized stay	Complication assessment by Clavien-Dindo classification	Hospital stay
Rate of death during hospitalized stay	Check number of participants at death during hospitalized stay	Hospital stay
Rate of re-admission within 30 days	Check re-admission within 30 days after discharge	30 day after discharge
Fasting blood glucose	Fasting blood glucose in mg/dL	After surgery day 5-7
Insulin (Homa IR)		After surgery day 5-7
Gastrointestinal tolerance	Gastrointestinal tolerance including abdominal distention,nausea,vomiting and diarrhea	Baseline,Study day 10-14

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Narisorn Lakananurak, Doctor, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Malnutrition; Gastrointestinal Neoplasms
• Other Study ID Numbers: 0711/65

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No