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

NCT06085365 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2023-10-16

No results posted yet for this study

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

  • Gastrointestinal Tumors
  • Immunonutrition
  • Postoperative Adjuvant Chemotherapy

Interventions

DRUG

Immunonutrition （Su yusu)

Immunonutrition （Su yusu） 250ml oral twice a day d1-d21

DRUG

fluorouracil based chemotherapy regimens

fluorouracil based chemotherapy regimens

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085365 on ClinicalTrials.gov