Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors

Phase 3

Recruiting

• Conditions: Immunonutrition; Postoperative Adjuvant Chemotherapy; Gastrointestinal Tumors
• Interventions: Drug: Immunonutrition （Su yusu); Drug: fluorouracil based chemotherapy regimens

• Registration Number: NCT06085365
• Lead Sponsor: China Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-24
• Study First Submitted: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2024-07-24
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunonutrition Group	fluorouracil based chemotherapy regimens	Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
Placebo Group	fluorouracil based chemotherapy regimens	normal diet group
Immunonutrition Group	Immunonutrition （Su yusu)	Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles

Primary Outcome Measures

Name	Time	Method
the incidence of chemotherapy related adverse reactions	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)	including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.

Secondary Outcome Measures

Name	Time	Method
survival time	1-year	1-year progression free survival rate
nutritional risk score	the first two cycles of chemotherapy. (each cycle is 21 days)	(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.
quality of life score	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)	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
changes in immune microenvironment	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)	Intestinal flora changes
treatment tolerance	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China