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ONS in Gastric Cancer After Total Gastrectomy

Primary Purpose

Gastric Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ONS

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Oral nutritional supplement, Sarcopenia, long-term nutritional status

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent of patients or their legal representatives to participate in this study consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy) nutrition Risk Screening (NRS) 2002≥3 at discharge eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge normal liver and kidney function Exclusion Criteria: unable to oral or consume ONS allergy to any ingredient in the oral nutrition powder pregnancy palliative surgery or gastric stump cancer congenital acquired immune deficiency disease severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications motor system diseases cannot complete grip strength measurement and 5-time chair stand test have cognitive impairment, unable to complete the relevant questionnaires expected to require tube feeding after discharge from the hospital

Sites / Locations

Jinling Hospital, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oral nutritional supplement

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

incidence of sarcopenia 6-month after discharge

sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

Secondary Outcome Measures

incidence of sarcopenia 1 year after discharge

sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

unplanned readmission rate

readmission due to unplanned reason

toxicity of chemotherapy graded according to the CTCAE, version 5.0

Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.

Quality of life after discharge

Quality of life assessed by EORTC QLQ-C30

Changes in BMI (weight and height will be combined to report BMI in kg/m^2)

nutritional status after discharge

Full Information

NCT ID

NCT05823272

First Posted

April 10, 2023

Last Updated

April 10, 2023

Sponsor

Jinling Hospital, China

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05823272

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 5, 2023 (Anticipated)

Primary Completion Date

August 5, 2024 (Anticipated)

Study Completion Date

August 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Oral nutritional supplement, Sarcopenia, long-term nutritional status

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oral nutritional supplement

Arm Type

Experimental

Arm Description

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.

Arm Title

control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

ONS

Intervention Description

oral nutritional supplement

Primary Outcome Measure Information:

Title

incidence of sarcopenia 6-month after discharge

Description

sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

Time Frame

up to 6 months.

Secondary Outcome Measure Information:

Title

incidence of sarcopenia 1 year after discharge

Description

sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

Time Frame

up to 12 months.

Title

unplanned readmission rate

Description

readmission due to unplanned reason

Time Frame

up to 6 months.

Title

toxicity of chemotherapy graded according to the CTCAE, version 5.0

Description

Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.

Time Frame

up to 6 months.

Title

Quality of life after discharge

Description

Quality of life assessed by EORTC QLQ-C30

Time Frame

up to 12 months.

Title

Changes in BMI (weight and height will be combined to report BMI in kg/m^2)

Description

nutritional status after discharge

Time Frame

up to 12 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tingting Gao, MS

Phone

15312311968

gaotting77@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xinying Wang, MD

Organizational Affiliation

Jinling Hosptial

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jinling Hospital, China

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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ONS in Gastric Cancer After Total Gastrectomy

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