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

Primary Purpose

Stage III Gastric Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ONS

About this trial

This is an interventional treatment trial for Stage III Gastric Cancer focused on measuring Oral nutritional supplement, Immunonutrition, long-term survival

Eligibility Criteria

18 Years - undefined (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 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
nutrition Risk Screening (NRS) 2002≥3 at discharge
eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge

Exclusion Criteria:

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

Sites / Locations

Jinling Hospital, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

immune nutrition support

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

3-year disease free survival after discharge

from date of randomization to disease recurrence or death

Secondary Outcome Measures

3-year overall survival

from date of randomization to death due to any reason,

unplanned readmission rate

readmission due to unplanned reason

Quality of life after discharge

Quality of life assessed by EORTC QLQ-C30

incidence of sarcopenia after discharge

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

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

nutritional status after discharge

Changes in albumin level

nutritional status after discharge

Changes in prealbumin level

nutritional status after discharge

Changes in hemoglobin level

nutritional status after discharge

Changes in weight

nutritional status after discharge

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.

Full Information

NCT ID

NCT05253716

First Posted

February 14, 2022

Last Updated

August 25, 2022

Sponsor

Jinling Hospital, China

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05253716

Brief Title

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

Acronym

CRUCIAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

March 2026 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

Collaborators

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 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.

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.

6. Conditions and Keywords

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

Stage III Gastric Cancer

Keywords

Oral nutritional supplement, Immunonutrition, long-term survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

696 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

immune nutrition support

Arm Type

Experimental

Arm Description

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

Other Intervention Name(s)

fish oil

Intervention Description

Immunonutritional supplement

Primary Outcome Measure Information:

Title

3-year disease free survival after discharge

Description

from date of randomization to disease recurrence or death

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

3-year overall survival

Description

from date of randomization to death due to any reason,

Time Frame

up to 3 years.

Title

unplanned readmission rate

Description

readmission due to unplanned reason

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

incidence of sarcopenia 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

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.

Title

Changes in albumin level

Description

nutritional status after discharge

Time Frame

up to 12 months.

Title

Changes in prealbumin level

Description

nutritional status after discharge

Time Frame

up to 12 months.

Title

Changes in hemoglobin level

Description

nutritional status after discharge

Time Frame

up to 12 months.

Title

Changes in weight

Description

nutritional status after discharge

Time Frame

up to 12 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent of patients or their legal representatives to participate in this study consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III nutrition Risk Screening (NRS) 2002≥3 at discharge eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge Exclusion Criteria: unable to oral or consume ONS has received neoadjuvant chemotherapy pregnancy palliative surgery or gastric stump cancer or Borrmann type IV oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications previous use of drugs affecting immune function previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule motor system diseases cannot complete grip strength measurement and 5-time chair stand test

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinying Wang, MD

Phone

+86 13913028866

wxinying@263.com

First Name & Middle Initial & Last Name & Degree

Da Zhou, MD

Phone

+8617625934081

zd21701107@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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26583669

Citation

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

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