Clinical trial NCT05823272: ONS in Gastric Cancer After Total Gastrectomy
Official title: Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: Oral nutritional supplement
Sarcopenia
long-term nutritional status
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
name: Shandong Provincial Hospital
name: Hebei Medical University Fourth Hospital
name: Zunyi Medical College
name: Xinqiao Hospital of Chongqing
First posted: 2023-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.

Detailed description: Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) 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 (18-80 years) patients underwent radical gastrectomy (total gastrectomy)
3. nutrition Risk Screening (NRS) 2002≥3 at discharge
4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
5. normal liver and kidney function

Exclusion Criteria:

1. unable to oral or consume ONS
2. allergy to any ingredient in the oral nutrition powder
3. pregnancy
4. palliative surgery or gastric stump cancer
5. congenital acquired immune deficiency disease
6. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications
7. motor system diseases cannot complete grip strength measurement and 5-time chair stand test
8. have cognitive impairment, unable to complete the relevant questionnaires
9. expected to require tube feeding after discharge from the hospital

Primary outcomes:
measure: incidence of sarcopenia 6-month after discharge
timeFrame: up to 6 months.
Secondary outcomes:
measure: incidence of sarcopenia 1 year after discharge
timeFrame: up to 12 months.
measure: unplanned readmission rate
timeFrame: up to 6 months.
measure: toxicity of chemotherapy graded according to the CTCAE, version 5.0
timeFrame: up to 6 months.
measure: Quality of life 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.
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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