Trials / Unknown
UnknownNCT06085365
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
A Multicenter, Open-label, Parallel Controlled, Prospective Cohort Study Evaluating Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 324 (estimated)
- Sponsor
- China Medical University, China · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immunonutrition （Su yusu) | Immunonutrition （Su yusu） 250ml oral twice a day d1-d21 |
| DRUG | fluorouracil based chemotherapy regimens | fluorouracil based chemotherapy regimens |
Timeline
- Start date
- 2023-07-24
- Primary completion
- 2024-07-24
- Completion
- 2024-12-31
- First posted
- 2023-10-16
- Last updated
- 2023-10-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06085365. Inclusion in this directory is not an endorsement.