Clinical trial · Interventional
Effect of Immune Formula in Gastrointestinal Cancer Patients Undergoing Cancer Surgery
Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Nutrition supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling
- interventionNames
- Dietary Supplement: Oral Nutrition supplement
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling
Primary outcomes (3)
- measure
- Change in C-reactive protein
- timeFrame
- Baseline,Study day 10-14, After surgery day 5-7
- description
- C-reactive protein in mg/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLakananurak 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 Apr;72:102909. doi: 10.1016/j.clnesp.2026.102909. Epub 2026 Jan 10. PMID 41525872