Novel immune-modulating formula versus standard formula for gastrointestinal cancer patients at risk of malnutrition undergoing surgery: A pilot randomized controlled trial.

BACKGROUND & AIMS: Malnutrition is prevalent among gastrointestinal cancer patients undergoing surgery. The European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines recommend 10-14 days of preoperative nutrition therapy for patients at nutritional risk, and perioperative immunonutrition to improve outcomes. However, benefits of preoperative immunonutrients versus standard formulas remain unclear. This study evaluated a novel curcumin-containing immunonutrient formula compared to a standard formula administered for 10-14 days preoperatively in gastrointestinal cancer patients at nutritional risk.

METHODS

This is a randomized, double-blind pilot trial. Patients with Nutrition Risk Score (NRS)2002 ≥ 3 were assigned to receive 2 servings/day (360 kcal, 17 g protein per serving) of either the immunonutrient or standard formula. Serum high-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha were measured at baseline, preoperative, and postoperative periods. Nutrition outcomes, complications, hospital stay, 30-day readmission, mortality, compliance, and acceptance were assessed.

RESULTS

Thirty patients were enrolled (15 per group). Preoperative immunonutrient supplementation was associated with a significant reduction in preoperative hs-CRP concentrations (-4.4 vs. 4.5 mg/L, p = 0.030) and a greater increase in body weight (1.9 vs. 0.3 kg, p = 0.041) compared with the standard formula. No significant differences were observed in postoperative complications, hospital stay, readmission, or mortality. Compliance and acceptance of the novel formula were high, with minimal gastrointestinal adverse events.

CONCLUSIONS

Preoperative supplementation with the curcumin-containing immunonutrient for 10-14 days reduced preoperative inflammatory response and greater weight gain compared to the standard formula in gastrointestinal cancer patients at nutritional risk. Further studies with larger populations are needed to validate these findings.

REGISTRATION NUMBER: ClinicalTrials.gov (NCT06825221).