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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