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

Stage III Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253716
• Other study ID #: 2021-12-4
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 2026

Study information

• Verified date: August 2022
• Source: Jinling Hospital, China
• Contact: Tingting Gao, MS
• Phone: 15312311968
• Email: gaotting77[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 696
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stage III Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• ONS
Immunonutritional supplement

Locations

Country	Name	City	State
China	Jinling Hospital, China	Nanjing	Jiangsu

Sponsors (12)

Lead Sponsor

Collaborator

Jinling Hospital, China

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

Country where clinical trial is conducted

China, 

References & Publications (13)

Heneghan HM, Zaborowski A, Fanning M, McHugh A, Doyle S, Moore J, Ravi N, Reynolds JV. Prospective Study of Malabsorption and Malnutrition After Esophageal and Gastric Cancer Surgery. Ann Surg. 2015 Nov;262(5):803-7; discussion 807-8. doi: 10.1097/SLA.0000000000001445. — View Citation

Huang DD, Cai HY, Chen XY, Dong WX, Wangchuk D, Yan JY, Chen XL, Dong QT. Value of Sarcopenia defined by the new EWGSOP2 consensus for the prediction of Postoperative Complications and Long-term Survival after Radical Gastrectomy for Gastric Cancer: A comparison with four common nutritional screening tools. J Cancer. 2020 Aug 6;11(19):5852-5860. doi: 10.7150/jca.49815. eCollection 2020. — View Citation

Huang YH, Chiu WC, Hsu YP, Lo YL, Wang YH. Effects of Omega-3 Fatty Acids on Muscle Mass, Muscle Strength and Muscle Performance among the Elderly: A Meta-Analysis. Nutrients. 2020 Dec 4;12(12). pii: E3739. doi: 10.3390/nu12123739. — View Citation

Lee JK, Park YS, Lee K, Youn SI, Won Y, Min SH, Ahn SH, Park DJ, Kim HH. Prognostic significance of surgery-induced sarcopenia in the survival of gastric cancer patients: a sex-specific analysis. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1897-1907. doi: 10.1002/jcsm.12793. Epub 2021 Sep 17. — View Citation

Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8. — View Citation

Meng Q, Tan S, Jiang Y, Han J, Xi Q, Zhuang Q, Wu G. Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. Clin Nutr. 2021 Jan;40(1):40-46. doi: 10.1016/j.clnu.2020.04.043. Epub 2020 Jun 2. — View Citation

Miyazaki Y, Omori T, Fujitani K, Fujita J, Kawabata R, Imamura H, Okada K, Moon JH, Hirao M, Matsuyama J, Saito T, Takahashi T, Kurokawa Y, Yamasaki M, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Oral nutritional supplements versus a regular diet alone for body weight loss after gastrectomy: a phase 3, multicenter, open-label randomized controlled trial. Gastric Cancer. 2021 Sep;24(5):1150-1159. doi: 10.1007/s10120-021-01188-3. Epub 2021 Apr 9. — View Citation

Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hütterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Mühlebach 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. — View Citation

Oh SE, Choi MG, Seo JM, An JY, Lee JH, Sohn TS, Bae JM, Kim S. Prognostic significance of perioperative nutritional parameters in patients with gastric cancer. Clin Nutr. 2019 Apr;38(2):870-876. doi: 10.1016/j.clnu.2018.02.015. Epub 2018 Feb 20. — View Citation

Ongaro E, Buoro V, Cinausero M, Caccialanza R, Turri A, Fanotto V, Basile D, Vitale MG, Ermacora P, Cardellino GG, Nicoletti L, Fornaro L, Casadei-Gardini A, Aprile G. Sarcopenia in gastric cancer: when the loss costs too much. Gastric Cancer. 2017 Jul;20(4):563-572. doi: 10.1007/s10120-017-0722-9. Epub 2017 May 5. Review. — View Citation

Ortega L, Lobos-González L, Reyna-Jeldes M, Cerda D, De la Fuente-Ortega E, Castro P, Bernal G, Coddou C. The O-3 fatty acid docosahexaenoic acid selectively induces apoptosis in tumor-derived cells and suppress tumor growth in gastric cancer. Eur J Pharmacol. 2021 Apr 5;896:173910. doi: 10.1016/j.ejphar.2021.173910. Epub 2021 Jan 26. Erratum in: Eur J Pharmacol. 2021 Sep 5;906:174287. — View Citation

Park JH, Kim E, Seol EM, Kong SH, Park DJ, Yang HK, Choi JH, Park SH, Choe HN, Kweon M, Park J, Choi Y, Lee HJ. Prediction Model for Screening Patients at Risk of Malnutrition After Gastric Cancer Surgery. Ann Surg Oncol. 2021 Aug;28(8):4471-4481. doi: 10.1245/s10434-020-09559-3. Epub 2021 Jan 22. — View Citation

Zheng HL, Lu J, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu R, Huang CM, Zheng CH. Effects of Preoperative Malnutrition on Short- and Long-Term Outcomes of Patients with Gastric Cancer: Can We Do Better? Ann Surg Oncol. 2017 Oct;24(11):3376-3385. doi: 10.1245/s10434-017-5998-9. Epub 2017 Jul 11. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival after discharge	from date of randomization to disease recurrence or death	up to 3 years
Secondary	3-year overall survival	from date of randomization to death due to any reason,	up to 3 years.
Secondary	unplanned readmission rate	readmission due to unplanned reason	up to 6 months.
Secondary	Quality of life after discharge	Quality of life assessed by EORTC QLQ-C30	up to 12 months.
Secondary	incidence of sarcopenia after discharge	sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.	up to 12 months.
Secondary	Changes in BMI (weight and height will be combined to report BMI in kg/m^2)	nutritional status after discharge	up to 12 months.
Secondary	Changes in albumin level	nutritional status after discharge	up to 12 months.
Secondary	Changes in prealbumin level	nutritional status after discharge	up to 12 months.
Secondary	Changes in hemoglobin level	nutritional status after discharge	up to 12 months.
Secondary	Changes in weight	nutritional status after discharge	up to 12 months.
Secondary	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.	up to 6 months.