ONS in Gastric Cancer After Total Gastrectomy

A study testing ONS in people with Gastric Cancer, run by Jinling Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastric Cancer
What is being tested?: ONS
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 22 Mar 2024to 5 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

Tingting Gao, MS contact

15312311968

gaotting77@163.com

China1 site, 1 recruiting

Jinling Hospital, China
Nanjing, Jiangsu, 210002
Xinying Wang, MD, +86 13913028866, wxinying@263.com
Da Zhou, MD, +8617625934081, zd21701107@163.com
Recruiting

Other trials in China

About this study

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

Read the detailed 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.

Conditions: Gastric Cancer
Being tested: ONS
Keywords: Oral nutritional supplement, Sarcopenia, long-term nutritional status
Medical subject headings: Stomach Neoplasms, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ONSOther
oral nutritional supplement

Study groups in NCT05823272
Study group	Role	What they receive
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. Receives: Other: ONS
control	No intervention	In the control group, patients will receive nutrition counseling in addition to diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

incidence of sarcopenia 6-month after discharge
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Measured: up to 6 months.

Secondary outcomes (5)

incidence of sarcopenia 1 year after discharge
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Measured: up to 12 months.
unplanned readmission rate
readmission due to unplanned reason
Measured: up to 6 months.
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.
Measured: up to 6 months.
Quality of life after discharge
Quality of life assessed by EORTC QLQ-C30
Measured: up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
nutritional status after discharge
Measured: up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20245 Aug 2024

First posted21 Apr 2023
Study start22 Mar 2024 (estimated)
Primary completion5 Aug 2024 (estimated)
Study completion5 Aug 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05823272
Sponsor's protocol ID: 2022-7-4
Status last verified: Mar 2024
First submitted: 10 Apr 2023
Last updated: 22 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31135850
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.
PubMed 34620108
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.
PubMed 34090215
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.
PubMed 26732274
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.
PubMed 31509590
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.
PubMed 21296615
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.
PubMed 29633095
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.
PubMed 34533290
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.
PubMed 30005807
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.
PubMed 30478682
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.
PubMed 33835329
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.
PubMed 32563598

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy
ClinicalTrials.gov ID: NCT05823272
Acronym / sponsor ID: 2022-7-4
Conditions: Gastric Cancer
Keywords: Oral nutritional supplement, Sarcopenia, long-term nutritional status
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Jinling Hospital, ChinaUniversity, hospital or other
Collaborators: Zhongda Hospital, Shandong Provincial Hospital, Hebei Medical University Fourth Hospital, Zunyi Medical College, Xinqiao Hospital of Chongqing
Study start: 22 Mar 2024 (estimated)
Primary completion: 5 Aug 2024 (estimated)
Study completion: 5 Aug 2024 (estimated)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary and secondary outcomes will be collected.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
oral nutritional supplement	Experimental	Other: ONSIn 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.
control	No intervention	–In the control group, patients will receive nutrition counseling in addition to diet.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ONSoral nutritional supplement	Other	oral nutritional supplement

Primary outcome

incidence of sarcopenia 6-month after discharge
Time frame: up to 6 months.
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

5 secondary outcomes

incidence of sarcopenia 1 year after discharge
Time frame: up to 12 months.
unplanned readmission rate
Time frame: up to 6 months.
toxicity of chemotherapy graded according to the CTCAE, version 5.0
Time frame: up to 6 months.
Quality of life after discharge
Time frame: up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
Time frame: up to 12 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
Background: PubMed 31135850Yu 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.
Background: PubMed 34620108Deng 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.
Background: PubMed 34090215Li 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.
Background: PubMed 26732274Davis 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.
Background: PubMed 31509590Takahashi 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.
Background: PubMed 21296615Fearon 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.
Background: PubMed 29633095Kawamura 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.
Background: PubMed 34533290Lee 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.
Background: PubMed 30005807Kudou 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.
Background: PubMed 30478682Kudou 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.
Background: PubMed 33835329Miyazaki 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.
Background: PubMed 32563598Meng 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tingting Gao, MS contact

15312311968

gaotting77@163.com

Xinying Wang, MD principal investigator

Jinling Hosptial

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ONS in people with Gastric Cancer, run by Jinling Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tingting Gao, MS (15312311968, gaotting77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of sarcopenia 6-month after discharge (time frame: up to 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05823272, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.