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Trial Title: ONS in Gastric Cancer After Total Gastrectomy

NCT ID: NCT05823272

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Conditions: Keywords:
Oral nutritional supplement
Sarcopenia
long-term nutritional status

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: ONS
Description: oral nutritional supplement
Arm group label: oral nutritional supplement

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Jinling Hospital, China

Address:
City: Nanjing
Zip: 210002
Country: China

Status: Recruiting

Contact:
Last name: Xinying Wang, MD

Phone: +86 13913028866
Email: wxinying@263.com

Contact backup:
Last name: Da Zhou, MD

Phone: +8617625934081
Email: zd21701107@163.com

Start date: March 22, 2024

Completion date: August 5, 2024

Lead sponsor:
Agency: Jinling Hospital, China
Agency class: Other

Collaborator:
Agency: Zhongda Hospital
Agency class: Other

Collaborator:
Agency: Shandong Provincial Hospital
Agency class: Other

Collaborator:
Agency: Hebei Medical University Fourth Hospital
Agency class: Other

Collaborator:
Agency: Zunyi Medical College
Agency class: Other

Collaborator:
Agency: Xinqiao Hospital of Chongqing
Agency class: Other

Source: Jinling Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05823272

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