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

October 13, 2023 updated by: Yunpeng Liu, China Medical University, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
normal diet group
Drug: fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
Experimental: Immunonutrition Group
Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles
Drug: fluorouracil based chemotherapy regimens
fluorouracil based chemotherapy regimens
Drug: Immunonutrition （Su yusu)
Immunonutrition （Su yusu） 250ml oral twice a day d1-d21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of chemotherapy related adverse reactions
Time Frame: 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.
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life score
Time Frame: 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
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
nutritional risk score
Time Frame: 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.
the first two cycles of chemotherapy. (each cycle is 21 days)
changes in immune microenvironment
Time Frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
cytokines (pg/ml)
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
survival time
Time Frame: 1-year
1-year progression free survival rate
1-year
treatment tolerance
Time Frame: 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
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
changes in immune microenvironment
Time Frame: the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)
Intestinal flora changes
the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

July 24, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 30, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOG2301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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