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

NCT05253716 | Recruiting DMC

• 1 other identifier: 2021-12-4
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Gastric Cancer

Keywords

Oral nutritional supplement; Immunonutrition; long-term survival

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival after discharge

  from date of randomization to disease recurrence or death

  up to 3 years

Secondary Outcomes (10)

• 3-year overall survival

  up to 3 years.

• unplanned readmission rate

  up to 6 months.

• Quality of life after discharge

  up to 12 months.

• incidence of sarcopenia after discharge

  up to 12 months.

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

  up to 12 months.

Study Arms (2)

immune nutrition support

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

ONS OTHER

Immunonutritional supplement

Also known as: fish oil

immune nutrition support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Affiliated cancer hospital of Nanjing Medical University: collaborator
• Nanjing Jiangning Hospital: collaborator
• Zhenjiang First People's Hospital: collaborator
• The Third Affiliated Hospital of Soochow University: collaborator
• ChangZhou Second hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Yixing People's Hospital: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• Wuxi People's Hospital: collaborator

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (14)

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• Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

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• Zhou D, Liu Y, Zhang L, Lu M, Gao X, Li G, Xiang X, Xu H, Li G, Sun Z, Wei W, Yi K, Zuo J, Wu Y, Qian J, Zhou J, Duan K, Wu Y, Tian Z, Jiang C, Wang X. Effects of oral immunonutritional supplement on 3-year disease-free survival in gastric cancer patients with pathological stage III after total gastrectomy (CRUCIAL): study protocol of a multicentre, randomised clinical trial. BMJ Open. 2023 Apr 11;13(4):e067990. doi: 10.1136/bmjopen-2022-067990.

  PMID: 37041057 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Xinying Wang, MD

  Jinling Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Gao, MS

CONTACT

15312311968; gaotting77@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)