Clinical trial NCT06085365: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastrointestinal Tumors
Immunonutrition
Postoperative Adjuvant Chemotherapy
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: the incidence of chemotherapy related adverse reactions
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary outcomes:
measure: quality of life score
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
measure: nutritional risk score
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 days)
measure: changes in immune microenvironment
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
measure: survival time
timeFrame: 1-year
measure: treatment tolerance
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
measure: changes in immune microenvironment
timeFrame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
References: