ONS in Gastric Cancer After Total Gastrectomy

NCT05823272 | Recruiting DMC

• 1 other identifier: 2022-7-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Oral nutritional supplement; Sarcopenia; long-term nutritional status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• incidence of sarcopenia 1 year after discharge

  up to 12 months.

• unplanned readmission rate

  up to 6 months.

• toxicity of chemotherapy graded according to the CTCAE, version 5.0

  up to 6 months.

• Quality of life 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)

oral nutritional supplement

EXPERIMENTAL

In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge.

Other: ONS

control

NO INTERVENTION

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

Interventions

ONS OTHER

oral nutritional supplement

oral nutritional supplement

Eligibility Criteria

• Age: 18 Years - 80 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 (18-80 years) patients underwent radical gastrectomy (total gastrectomy)
• nutrition Risk Screening (NRS) 2002≥3 at discharge
• eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
• normal liver and kidney function

You may not qualify if:

• unable to oral or consume ONS
• allergy to any ingredient in the oral nutrition powder
• pregnancy
• palliative surgery or gastric stump cancer
• congenital acquired immune deficiency disease
• severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications
• motor system diseases cannot complete grip strength measurement and 5-time chair stand test
• have cognitive impairment, unable to complete the relevant questionnaires
• expected to require tube feeding after discharge from the hospital

Sponsors & Collaborators

• Jinling Hospital, China: lead
• Zhongda Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Zunyi Medical College: collaborator
• Xinqiao Hospital of Chongqing: collaborator

Study Sites (1)

Jinling Hospital, China

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 31135850 BACKGROUND

• 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.

  PMID: 34620108 BACKGROUND

• 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.

  PMID: 34090215 BACKGROUND

• 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.

  PMID: 26732274 BACKGROUND

• 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.

  PMID: 31509590 BACKGROUND

• 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.

  PMID: 21296615 BACKGROUND

• 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.

  PMID: 29633095 BACKGROUND

• 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.

  PMID: 34533290 BACKGROUND

• 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.

  PMID: 30005807 BACKGROUND

• 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.

  PMID: 30478682 BACKGROUND

• 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.

  PMID: 33835329 BACKGROUND

• 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.

  PMID: 32563598 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

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: April 10, 2023
• First Posted: April 21, 2023
• Study Start: March 22, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)