Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer (CRUCIAL)

August 25, 2022 updated by: Wang Xinying, Jinling Hospital, China

The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer

Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support 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 with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil 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 (Anticipated)

696

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Informed consent of patients or their legal representatives to participate in this study
  2. consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
  3. nutrition Risk Screening (NRS) 2002≥3 at discharge
  4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge

Exclusion Criteria:

  1. unable to oral or consume ONS
  2. has received neoadjuvant chemotherapy
  3. pregnancy
  4. palliative surgery or gastric stump cancer or Borrmann type IV
  5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
  6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
  7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
  8. diabetes has developed complications or uncontrolled by medications
  9. previous use of drugs affecting immune function
  10. previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule
  11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test

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
Experimental: immune nutrition support
In the immune nutrition support group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil after discharge lasted for 6 months.
Other: ONS
Immunonutritional supplement
Other Names:
  • fish oil
No Intervention: control
In the control group, patients will receive nutrition counseling in addition to diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival after discharge
Time Frame: up to 3 years
from date of randomization to disease recurrence or death
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: up to 3 years.
from date of randomization to death due to any reason,
up to 3 years.
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.
incidence of sarcopenia 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.
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.
Changes in albumin level
Time Frame: up to 12 months.
nutritional status after discharge
up to 12 months.
Changes in prealbumin level
Time Frame: up to 12 months.
nutritional status after discharge
up to 12 months.
Changes in hemoglobin level
Time Frame: up to 12 months.
nutritional status after discharge
up to 12 months.
Changes in weight
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.

Collaborators and Investigators

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

Sponsor

Jinling Hospital, China

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Soochow University
Zhenjiang First People's Hospital
Second Affiliated Hospital of Soochow University
Wuxi People's Hospital
The Second Hospital of Nanjing Medical University
The Third Affiliated Hospital of Soochow University
The Affiliated cancer hospital of Nanjing Medical University
Nanjing Jiangning Hospital
ChangZhou Second hospital
Yixing People's Hospital

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 (Actual)

August 1, 2022

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12-4

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.

Clinical Trials on Stage III Gastric Cancer

Clinical Trials on ONS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe