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

Gastrointestinal Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085365
• Other study ID #: CLOG2301
• Status: Recruiting
• Phase: Phase 3
• Start date: July 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: China Medical University, China
• Contact: Xiujuan Qu
• Phone: 86-24-83282312
• Email: xiujuanqu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: December 31, 2024
• Est. primary completion date: July 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Tumors
• Immunonutrition

Intervention

Drug:
• Immunonutrition (Su yusu)
Immunonutrition (Su yusu) 250ml oral twice a day d1-d21
• fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens

Locations

Country	Name	City	State
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of chemotherapy related adverse reactions	including bone marrow suppression, nausea and vomiting, diarrhea, and mucositis and so on.	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary	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	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary	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.	the first two cycles of chemotherapy. (each cycle is 21 days)
Secondary	changes in immune microenvironment	cytokines (pg/ml)	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary	survival time	1-year progression free survival rate	1-year
Secondary	treatment tolerance	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Secondary	changes in immune microenvironment	Intestinal flora changes	the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)