Immunonutrition's effects on chemotherapy side effects in gastrointestinal cancer patients

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

This study is testing if an immunonutrition supplement can help people with gastrointestinal cancer feel better and have fewer side effects from their chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China Medical University, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06085365 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of Suyusu, an immunonutrition supplement, on reducing adverse reactions associated with postoperative adjuvant chemotherapy in patients with gastrointestinal tumors. The study focuses on measuring the incidence of chemotherapy-related side effects such as nausea, vomiting, and bone marrow suppression after two cycles of treatment. Additionally, it assesses quality of life, nutritional status, immune microenvironment changes, and psychological well-being. The trial aims to provide insights into how immunonutrition can improve treatment tolerance and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with stage II-III gastrointestinal malignancies who are undergoing radical surgery and have not yet received adjuvant chemotherapy.

Not a fit: Patients with allergies to immunonutrition components, those with immune deficiencies, or those currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the adverse effects of chemotherapy, improving the quality of life for patients undergoing treatment for gastrointestinal tumors.

How similar studies have performed: While the specific approach of using Suyusu in this context may be novel, similar studies have shown promising results in using immunonutrition to mitigate chemotherapy side effects.

Eligibility criteria

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.

Where this trial is running

Shenyang, Liaoning

• The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Study coordinator: Xiujuan Qu

Conditions: Gastrointestinal Tumors, Immunonutrition, Postoperative Adjuvant Chemotherapy