Back to resultsEffects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
Primary Purpose
Gastrointestinal Tumors, Immunonutrition, Postoperative Adjuvant Chemotherapy
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Immunonutrition （Su yusu)
fluorouracil based chemotherapy regimens
Sponsored by
About this trial
This is an interventional prevention trial for Gastrointestinal Tumors
Eligibility Criteria
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.
Sites / Locations
- The First Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo Group
Immunonutrition Group
Arm Description
normal diet group
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
Outcomes
Primary Outcome Measures
the incidence of chemotherapy related adverse reactions
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
Secondary Outcome Measures
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
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.
changes in immune microenvironment
cytokines (pg/ml)
survival time
1-year progression free survival rate
treatment tolerance
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
changes in immune microenvironment
Intestinal flora changes
Full Information
NCT ID
NCT06085365
First Posted
September 30, 2023
Last Updated
October 13, 2023
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT06085365
Brief Title
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
July 24, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Tumors, Immunonutrition, Postoperative Adjuvant Chemotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
normal diet group
Arm Title
Immunonutrition Group
Arm Type
Experimental
Arm Description
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
Intervention Type
Drug
Intervention Name(s)
Immunonutrition （Su yusu)
Intervention Description
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21
Intervention Type
Drug
Intervention Name(s)
fluorouracil based chemotherapy regimens
Intervention Description
fluorouracil based chemotherapy regimens
Primary Outcome Measure Information:
Title
the incidence of chemotherapy related adverse reactions
Description
including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary Outcome Measure Information:
Title
quality of life score
Description
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
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Title
nutritional risk score
Description
(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.
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 days)
Title
changes in immune microenvironment
Description
cytokines (pg/ml)
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Title
survival time
Description
1-year progression free survival rate
Time Frame
1-year
Title
treatment tolerance
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Title
changes in immune microenvironment
Description
Intestinal flora changes
Time Frame
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiujuan Qu
Phone
86-24-83282312
Email
xiujuanqu@yahoo.com
Facility Information:
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiujuan Qu, Doctor
Phone
13604031355
Email
cmu1h_zlnk_trial@163.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
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