Clinical trial · Interventional
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
- 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)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
| Immunonutrition | — | UNRESOLVED | — |
| Postoperative Adjuvant Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil based chemotherapy regimens | Drug | — | UNRESOLVED |
| Immunonutrition (Su yusu) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- normal diet group
- interventionNames
- Drug: fluorouracil based chemotherapy regimens
- type
- EXPERIMENTAL
- label
- Immunonutrition Group
- description
- Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
- interventionNames
- Drug: Immunonutrition (Su yusu)
- Drug: fluorouracil based chemotherapy regimens
Primary outcomes (1)
- measure
- the incidence of chemotherapy related adverse reactions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects voluntarily and sign an informed consent form; 2. Age ≥ 18 years old and ≤ 75 years old; 3. Patients with stage II-III gastrointestinal malignancies with clear pathological diagnosis and undergoing radical surgery 4. No adjuvant chemotherapy received after surgery 5. The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points; 6. No contraindications to chemotherapy and the use of fluorouracil based chemotherapy regimens; Exclusion Criteria: 1. Allergy to the components of immune nutrients, allergic constitution, or other inability to eat; 2. Participated in other drug or food clinical trials within 2 months prior to enrollment; 3. Having a history of immune deficiency, including HIV testing positive, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation, or active infections that are not suitable for chemotherapy (as determined by the researcher); 4. Subjects cannot guarantee compliance after participating in the study; 5. Other researchers believe that it is not suitable for enrollment.
References
Publications (0)
Data not yet available