Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer (CRUCIAL)

Jinling Hospital, China

Status: Enrolling

Conditions: Stage III Gastric Cancer

Treatments: Other: ONS

Study type: Interventional

Funder types: Other

Identifiers

NCT05253716

2021-12-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 696 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

696 participants in 2 patient groups

immune nutrition support

Experimental group

Description:

In the immune nutrition support 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 after discharge lasted for 6 months.

Treatment:

Other: ONS

control

No Intervention group

Description:

In the control group, patients will receive nutrition counseling in addition to diet.