Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery

NCT06825221 | Completed

• 1 other identifier: 0711/65
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in Prealbumin

  Baseline,Study day 10-14, After surgery day 5-7

• Mid-upper arm circumference

  Baseline,Study day 10-14, After surgery day 5-7

• BIA

  Baseline,Study day 10-14, After surgery day 5-7

• Handgrip strength

  Baseline,Study day 10-14, After surgery day 5-7

• Complication during hospitalized stay

  Hospital stay

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling

Dietary Supplement: Oral Nutrition supplement

Control group

NO INTERVENTION

Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling

Interventions

Oral Nutrition supplement DIETARY_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.

Also known as: Immune formula

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Department of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

• Lakananurak N, Laosuwan P, Vongwattanakit P, Jittivasurat A, Techasukthavorn V. Novel Immune-Modulating Formula Versus Standard Formula for Gastrointestinal Cancer Patients at Risk of Malnutrition Undergoing Surgery: A Pilot Randomized Controlled Trial. Clin Nutr ESPEN. 2026 Jan 10:102909. doi: 10.1016/j.clnesp.2026.102909. Online ahead of print.

  PMID: 41525872 DERIVED

MeSH Terms

Conditions

Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Narisorn Lakananurak, Doctor

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The same sachet, taste, and appearance for both formula * Care provider and outcome assessor will be blinded for study arm of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: April 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-01

Locations

TH (1)