drugset / Trial / NCT06085365

Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors

NCT06085365 ↗

Phase 3 Unknown 324 enrolled China Medical University, China
Non-randomizedParallel-groupTriple-blindPrevention

Summary

Evaluate the effects of Suyusu (immunonutrition) in postoperative adjuvant chemotherapy for gastrointestinal cancer patients. The main endpoint of the study was the incidence of chemotherapy related adverse reactions (including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis) in patients after two cycles of chemotherapy. The secondary endpoint indicators were: quality of life score (EORTC-QLQ-C30), nutritional risk score (PG-SGA, NRS2002), nutritional assessment indicators, changes in immune microenvironment, analysis of psychological status, survival time (1-year progression free survival rate), treatment tolerance (dose intensity, rate of treatment interruption, delay), etc.

Timeline

Start
2023-07-24
Primary completion
2024-07-24
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Su yusu Unknown 250 ml Oral