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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | normal diet group |
|
| Immunonutrition Group | Experimental | Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition (Su yusu) | Drug | Immunonutrition (Su yusu) 250ml oral twice a day d1-d21 |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiujuan Qu | Contact | 86-24-83282312 | xiujuanqu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
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| fluorouracil based chemotherapy regimens | Drug | fluorouracil based chemotherapy regimens |
|
| 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) |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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