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Trial Title:
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
NCT ID:
NCT06085365
Condition:
Gastrointestinal Tumors
Immunonutrition
Postoperative Adjuvant Chemotherapy
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Fluorouracil
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Immunonutrition （Su yusu)
Description:
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
Arm group label:
Immunonutrition Group
Intervention type:
Drug
Intervention name:
fluorouracil based chemotherapy regimens
Description:
fluorouracil based chemotherapy regimens
Arm group label:
Immunonutrition Group
Arm group label:
Placebo Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiujuan Qu, Doctor
Phone:
13604031355
Email:
cmu1h_zlnk_trial@163.com
Start date:
July 24, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
China Medical University, China
Agency class:
Other
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085365
