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

NCT06085365 | Unknown Phase 3 DMC

• 1 other identifier: CLOG2301
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Tumors; Immunonutrition; Postoperative Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• quality of life score

  the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)

• nutritional risk score

  the first two cycles of chemotherapy. (each cycle is 21 days)

• changes in immune microenvironment

  the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)

• survival time

  1-year

• treatment tolerance

  the first two cycles of chemotherapy. (each cycle is 21 ± 3 days)

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

normal diet group

Drug: fluorouracil based chemotherapy regimens

Immunonutrition Group

EXPERIMENTAL

Immunonutrition (Suyusu) 250ml oral twice one day d1-d21 for two cycles

Drug: Immunonutrition （Su yusu); Drug: fluorouracil based chemotherapy regimens

Interventions

Immunonutrition （Su yusu) DRUG

Immunonutrition （Su yusu） 250ml oral twice a day d1-d21

Immunonutrition Group

fluorouracil based chemotherapy regimens DRUG

fluorouracil based chemotherapy regimens

Immunonutrition Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily and sign an informed consent form;
• Age ≥ 18 years old and ≤ 75 years old;
• Patients with stage II-III gastrointestinal malignancies with clear pathological diagnosis and undergoing radical surgery
• No adjuvant chemotherapy received after surgery
• The Eastern Cancer Collaborative Group's Physical State Score (ECOG) is 0-2 points;
• No contraindications to chemotherapy and the use of fluorouracil based chemotherapy regimens;

You may not qualify if:

• Allergy to the components of immune nutrients, allergic constitution, or other inability to eat;
• Participated in other drug or food clinical trials within 2 months prior to enrollment;
• 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);
• Subjects cannot guarantee compliance after participating in the study;
• Other researchers believe that it is not suitable for enrollment.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Central Study Contacts

Xiujuan Qu

CONTACT

86-24-83282312; xiujuanqu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 16, 2023
• Study Start: July 24, 2023
• Primary Completion: July 24, 2024
• Study Completion: December 31, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

CN (1)