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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06085365
Other study ID # CLOG2301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
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