ONS in Gastric Cancer After Total Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823272
• Other study ID #: 2022-7-4
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: August 5, 2024

Study information

• Verified date: March 2024
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study

2. consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy)

3. nutrition Risk Screening (NRS) 2002=3 at discharge

4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge

5. normal liver and kidney function

Exclusion Criteria:

1. unable to oral or consume ONS

2. allergy to any ingredient in the oral nutrition powder

3. pregnancy

4. palliative surgery or gastric stump cancer

5. congenital acquired immune deficiency disease

6. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications

7. motor system diseases cannot complete grip strength measurement and 5-time chair stand test

8. have cognitive impairment, unable to complete the relevant questionnaires

9. expected to require tube feeding after discharge from the hospital

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• ONS
oral nutritional supplement

Locations

Country	Name	City	State
China	Jinling Hospital, China	Nanjing	Jiangsu

Sponsors (6)

Lead Sponsor	Collaborator
Jinling Hospital, China	Hebei Medical University Fourth Hospital, Shandong Provincial Hospital, Xinqiao Hospital of Chongqing, Zhongda Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (12)

Davis JL, Selby LV, Chou JF, Schattner M, Ilson DH, Capanu M, Brennan MF, Coit DG, Strong VE. Patterns and Predictors of Weight Loss After Gastrectomy for Cancer. Ann Surg Oncol. 2016 May;23(5):1639-45. doi: 10.1245/s10434-015-5065-3. Epub 2016 Jan 5. — View Citation

Deng ZJ, Nie RC, Lu J, Chen XJ, Xiang J, Huang CM, Chen YB, Peng JS, Chen S. Survival analysis of stage II gastric cancer patients after D2 gastrectomy: a Chinese people-based research. BMC Gastroenterol. 2021 Oct 7;21(1):363. doi: 10.1186/s12876-021-01937-9. — View Citation

Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. — View Citation

Kawamura T, Makuuchi R, Tokunaga M, Tanizawa Y, Bando E, Yasui H, Aoyama T, Inano T, Terashima M. Long-Term Outcomes of Gastric Cancer Patients with Preoperative Sarcopenia. Ann Surg Oncol. 2018 Jun;25(6):1625-1632. doi: 10.1245/s10434-018-6452-3. Epub 2018 Apr 9. — View Citation

Kudou K, Saeki H, Nakashima Y, Kimura K, Ando K, Oki E, Ikeda T, Maehara Y. Postoperative Skeletal Muscle Loss Predicts Poor Prognosis of Adenocarcinoma of Upper Stomach and Esophagogastric Junction. World J Surg. 2019 Apr;43(4):1068-1075. doi: 10.1007/s00268-018-4873-6. — View Citation

Kudou K, Saeki H, Nakashima Y, Sasaki S, Jogo T, Hirose K, Hu Q, Tsuda Y, Kimura K, Nakanishi R, Kubo N, Ando K, Oki E, Ikeda T, Maehara Y. Postoperative development of sarcopenia is a strong predictor of a poor prognosis in patients with adenocarcinoma of the esophagogastric junction and upper gastric cancer. Am J Surg. 2019 Apr;217(4):757-763. doi: 10.1016/j.amjsurg.2018.07.003. Epub 2018 Jul 10. — 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

Li Q, Zhang X, Tang M, Song M, Zhang Q, Zhang K, Ruan G, Zhang X, Ge Y, Yang M, Liu Y, Xu H, Song C, Wang Z, Shi H. Different muscle mass indices of the Global Leadership Initiative on Malnutrition in diagnosing malnutrition and predicting survival of patients with gastric cancer. Nutrition. 2021 Sep;89:111286. doi: 10.1016/j.nut.2021.111286. Epub 2021 Apr 24. — 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

Takahashi S, Shimizu S, Nagai S, Watanabe H, Nishitani Y, Kurisu Y. Characteristics of sarcopenia after distal gastrectomy in elderly patients. PLoS One. 2019 Sep 11;14(9):e0222412. doi: 10.1371/journal.pone.0222412. eCollection 2019. — View Citation

Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of sarcopenia 6-month after discharge	sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.	up to 6 months.
Secondary	incidence of sarcopenia 1 year after discharge	sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.	up to 12 months.
Secondary	unplanned readmission rate	readmission due to unplanned reason	up to 6 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.
Secondary	Quality of life after discharge	Quality of life assessed by EORTC QLQ-C30	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.