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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastrointestinal Tumors, Immunonutrition, Postoperative Adjuvant Chemotherapy

Intervention / Treatment
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* Drug: Immunonutrition （Su yusu)
* Drug: fluorouracil based chemotherapy regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily and sign an informed consent form; Age ≥ 18 years old and ≤ 75 years old; Patients with stage II-III gastrointestinal malignancies with clear pathological diagnosis and undergoing radical surgery No adjuvant chemotherapy received after surgery The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points; No contraindications to chemotherapy and the use of fluorouracil based chemotherapy regimens; Exclusion Criteria: Allergy to the components of immune nutrients, allergic constitution, or other inability to eat; Participated in other drug or food clinical trials within 2 months prior to enrollment; 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); Subjects cannot guarantee compliance after participating in the study; Other researchers believe that it is not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>normal diet group | Drug: fluorouracil based chemotherapy regimens<br>* fluorouracil based chemotherapy regimens<br>|
| Experimental: Immunonutrition Group<br>Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles | Drug: Immunonutrition （Su yusu)<br>* Immunonutrition （Su yusu） 250ml oral twice a day d1-d21<br>Drug: fluorouracil based chemotherapy regimens<br>* fluorouracil based chemotherapy regimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of chemotherapy related adverse reactions | including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on. | the first two cycles of chemotherapy. (each cycle is 21 ± 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life score | EORTC(The European Organization for Reasearch and Treatment of Cancer)-QOL-C30 (Quality of Life Questionnare-Core 30), patients need to answer all the questions by circling the number (1,2,3,4), big number means the worse quality of life score | the first two cycles of chemotherapy. (each cycle is 21 ± 3 days) | 
| nutritional risk score | (PG-SGA) the patient-generated subjective global assessment. The result (A means well-nourished, B means middling-cacotrophia, C means severe malnutrition). Nutritional risk Screening Form 2002 (NRS2002), score ≥3 means patients with nutritional risk, score <3 patients with no nutritional risk. We use the two methods to evaluate the nutritional risk score. | the first two cycles of chemotherapy. (each cycle is 21 days) | 
| changes in immune microenvironment | cytokines (pg/ml) | the first two cycles of chemotherapy. (each cycle is 21 ± 3 days) | 
| survival time | 1-year progression free survival rate | 1-year | 
| treatment tolerance | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | the first two cycles of chemotherapy. (each cycle is 21 ± 3 days) | 
| changes in immune microenvironment | Intestinal flora changes | the first two cycles of chemotherapy. (each cycle is 21 ± 3 days) |