Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery

Not Applicable

Completed

• Conditions: Malnutrition; Cancer

• Registration Number: NCT06825221
• Lead Sponsor: Chulalongkorn University

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.

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 Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand