Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery

NCT ID: NCT06825221

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-09-30

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.

Conditions

Malnutrition; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Oral Nutrition supplement

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Immune formula

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Narisorn Lakananurak, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Department of Medicine, Chulalongkorn University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

0711/65

Identifier Type: -

Identifier Source: org_study_id