Nutritional support after total stomach removal for stage III gastric cancer patients

The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer

This study is testing if a special high-calorie and high-protein diet with fish oil can help people with stage III gastric cancer feel better and live longer after having their stomach removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 696 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jinling Hospital, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05253716 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of immunonutritional support in patients with stage III gastric cancer following total gastrectomy. Participants will be randomly assigned to receive either a high-calorie, high-protein oral nutritional supplement along with fish oil capsules or a normal diet for six months after discharge. The study aims to assess the impact of this nutritional intervention on long-term survival and overall health outcomes. Both groups will also receive nutrition counseling to support their dietary needs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone total gastrectomy for stage III gastric cancer and have a nutrition risk score of 3 or higher.

Not a fit: Patients who are unable to consume oral nutritional supplements or have severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and improve long-term survival rates for patients with stage III gastric cancer.

How similar studies have performed: Previous studies have shown promising results with nutritional interventions in cancer recovery, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study
2. consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
3. nutrition Risk Screening (NRS) 2002≥3 at discharge
4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge

Exclusion Criteria:

1. unable to oral or consume ONS
2. has received neoadjuvant chemotherapy
3. pregnancy
4. palliative surgery or gastric stump cancer or Borrmann type IV
5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
8. diabetes has developed complications or uncontrolled by medications
9. previous use of drugs affecting immune function
10. previous use of fish oil capsule \> 2 times / week or contraindications to fish oil capsule
11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital, China — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Xinying Wang, MD — Jinling Hosptial
• Study coordinator: Tingting Gao, MS

Conditions: Stage III Gastric Cancer, Oral nutritional supplement, Immunonutrition, long-term survival