Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
NCT ID: NCT06085365
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
324 participants
INTERVENTIONAL
2023-07-24
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo Group
normal diet group
fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
Immunonutrition Group
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
Immunonutrition （Su yusu)
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
Interventions
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Immunonutrition （Su yusu)
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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China Medical University, China
OTHER
Responsible Party
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Yunpeng Liu
Clinical Professor
Locations
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The First Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLOG2301
Identifier Type: -
Identifier Source: org_study_id
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