Clinical trial NCT06825221: Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery
Official title: Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Cancer
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in C-reactive protein
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: Change in Tumor necrosis factor alpha (TNF-α)
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: Change in interleukin-6 (IL-6)
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
Secondary outcomes:
measure: Change in Prealbumin
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: Mid-upper arm circumference
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: BIA
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: Handgrip strength
timeFrame: Baseline,Study day 10-14, After surgery day 5-7
measure: Complication during hospitalized stay
timeFrame: Hospital stay
measure: Rate of death during hospitalized stay
timeFrame: Hospital stay
measure: Rate of re-admission within 30 days
timeFrame: 30 day after discharge
measure: Fasting blood glucose
timeFrame: After surgery day 5-7
measure: Insulin (Homa IR)
timeFrame: After surgery day 5-7
measure: Gastrointestinal tolerance
timeFrame: Baseline,Study day 10-14
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Narisorn Lakananurak, Doctor
role: PRINCIPAL_INVESTIGATOR
References: