Clinical trial NCT05253716: Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage III Gastric Cancer
Keywords: Oral nutritional supplement
Immunonutrition
long-term survival
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: The Affiliated cancer hospital of Nanjing Medical University
name: Nanjing Jiangning Hospital
name: Zhenjiang First People's Hospital
name: The Third Affiliated Hospital of Soochow University
name: ChangZhou Second hospital
name: The First Affiliated Hospital of Soochow University
name: Second Affiliated Hospital of Soochow University
name: Yixing People's Hospital
name: The Second Hospital of Nanjing Medical University
name: Wuxi People's Hospital
First posted: 2022-02-24
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.

Detailed description: Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.

The primary and secondary outcomes will be collected.

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

Primary outcomes:
measure: 3-year disease free survival after discharge
timeFrame: up to 3 years
Secondary outcomes:
measure: 3-year overall survival
timeFrame: up to 3 years.
measure: unplanned readmission rate
timeFrame: up to 6 months.
measure: Quality of life after discharge
timeFrame: up to 12 months.
measure: incidence of sarcopenia after discharge
timeFrame: up to 12 months.
measure: Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
timeFrame: up to 12 months.
measure: Changes in albumin level
timeFrame: up to 12 months.
measure: Changes in prealbumin level
timeFrame: up to 12 months.
measure: Changes in hemoglobin level
timeFrame: up to 12 months.
measure: Changes in weight
timeFrame: up to 12 months.
measure: toxicity of chemotherapy graded according to the CTCAE, version 5.0
timeFrame: up to 6 months.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, China
state: Jiangsu
Study officials:
affiliation: Jinling Hosptial
name: Xinying Wang, MD
role: PRINCIPAL_INVESTIGATOR
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