Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Group normal diet group |
Drug: fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
|
| Experimental: Immunonutrition Group Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles |
Drug: Immunonutrition （Su yusu)
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
Drug: fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
|
Outcome Measures
Primary Outcome Measures
- the incidence of chemotherapy related adverse reactions [the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)]
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
Secondary Outcome Measures
- quality of life score [the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)]
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
- nutritional risk score [the first two cycles of chemotherapy. (each cycle is 21 days)]
(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.
- changes in immune microenvironment [the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)]
cytokines (pg/ml)
- survival time [1-year]
1-year progression free survival rate
- treatment tolerance [the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- changes in immune microenvironment [the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)]
Intestinal flora changes
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects voluntarily and sign an informed consent form;
-
Age ≥ 18 years old and ≤ 75 years old;
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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:
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Allergy to the components of immune nutrients, allergic constitution, or other inability to eat;
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Participated in other drug or food clinical trials within 2 months prior to enrollment;
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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);
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Subjects cannot guarantee compliance after participating in the study;
-
Other researchers believe that it is not suitable for enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of China Medical University | Shenyang | Liaoning | China | 110000 |
Sponsors and Collaborators
- China Medical University, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLOG2301