ONS in Gastric Cancer After Total Gastrectomy

March 21, 2024 updated by: Wang Xinying, Jinling Hospital, China

Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
In the control group, patients will receive nutrition counseling in addition to diet.
Experimental: oral nutritional supplement
In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge.
Other: ONS
oral nutritional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of sarcopenia 6-month after discharge
Time Frame: up to 6 months.
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
up to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
unplanned readmission rate
Time Frame: up to 6 months.
readmission due to unplanned reason
up to 6 months.
Quality of life after discharge
Time Frame: up to 12 months.
Quality of life assessed by EORTC QLQ-C30
up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
Time Frame: up to 12 months.
nutritional status after discharge
up to 12 months.
toxicity of chemotherapy graded according to the CTCAE, version 5.0
Time Frame: up to 6 months.
Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.
up to 6 months.
incidence of sarcopenia 1 year after discharge
Time Frame: up to 12 months.
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Collaborators

Shandong Provincial Hospital
Hebei Medical University Fourth Hospital
Zhongda Hospital
Xinqiao Hospital of Chongqing
Zunyi Medical College

Investigators

  • Principal Investigator: Xinying Wang, MD, Jinling Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 22, 2024

Primary Completion (Estimated)

August 5, 2024

Study Completion (Estimated)

August 5, 2024

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-7-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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