Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer

Official title

A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer

Overview

The primary objectives of this study is o evaluate the safety of a leucine-restricted diet in patients with gastric cancer and determine the impact of a leucine-restricted diet on serum amino acid concentrations in patients with gastric cancer.Besides,we can assess changes in the immune microenvironment of gastric cancer patients following administration of a leucine-restricted diet and observe alterations in body composition of gastric cancer patients after the application of a leucine-restricted diet.

Interventions

• Dietary supplement Leucine-restricted diet.
  During the preoperative waiting period after hospital admission, study participants received a leucine-restricted diet for three days prior to surgery. Surgical intervention was performed immediately following the 3-day dietary intervention. Postoperatively, patients gradually resumed a regular diet according to standard surgical protocols.

Primary outcome measures

• Amino acid concentration [Time frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation]
• The adverse event of leucine-restricted diet in patients with gastric cancer [Time frame: 6 months after surgery]

Secondary outcome measures (1)

• CD8+ T cell percentage [Time frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.]

Eligibility criteria

Inclusion criteria

• Pathologically confirmed gastric carcinoma requiring preoperative endoscopic localization marking or delineation of the lesion extent.
• Aged between 18 and 70 years, regardless of gender.
• Ability to consume oral or nasogastric tube feeding of a liquid diet.
• Provision of signed informed consent and voluntary participation in this study.
• No evidence of distant metastasis on preoperative imaging studies (e.g., CT, PET-CT), and deemed suitable for surgical resection.
• No concurrent diagnosis of other active malignancies.

Exclusion criteria

• Presence of cognitive impairment or psychological disorders that may compromise the understanding of the research content.
• Diagnosis of Type I or Type II Diabetes Mellitus.
• Severe diarrhea, intractable vomiting, severe malabsorption syndromes, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding.
• Known allergy to the primary components of the leucine-deficient nutritional formula.
• Concurrent use of other nutritional supplements that may interfere with the trial's efficacy.
• Postoperative pathological diagnosis confirming non-primary gastric cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Publications

• Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available. PMID 35914639
• 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 PMID 33946039
• Powell JD, Pollizzi KN, Heikamp EB, Horton MR. Regulation of immune responses by mTOR. Annu Rev Immunol. 2012;30:39-68. doi: 10.1146/annurev-immunol-020711-075024. Epub 2011 Nov 29. PMID 22136167
• Delgoffe GM, Powell JD. mTOR: taking cues from the immune microenvironment. Immunology. 2009 Aug;127(4):459-65. doi: 10.1111/j.1365-2567.2009.03125.x. PMID 19604300
• Araki K, Ellebedy AH, Ahmed R. TOR in the immune system. Curr Opin Cell Biol. 2011 Dec;23(6):707-15. doi: 10.1016/j.ceb.2011.08.006. Epub 2011 Sep 16. PMID 21925855
• Passarelli MC, Pinzaru AM, Asgharian H, Liberti MV, Heissel S, Molina H, Goodarzi H, Tavazoie SF. Leucyl-tRNA synthetase is a tumour suppressor in breast cancer and regulates codon-dependent translation dynamics. Nat Cell Biol. 2022 Mar;24(3):307-315. doi: 10.1038/s41556-022-00856-5. Epub 2022 Mar 14. PMID 35288656
• Saito Y, Li L, Coyaud E, Luna A, Sander C, Raught B, Asara JM, Brown M, Muthuswamy SK. LLGL2 rescues nutrient stress by promoting leucine uptake in ER+ breast cancer. Nature. 2019 May;569(7755):275-279. doi: 10.1038/s41586-019-1126-2. Epub 2019 Apr 17. PMID 30996345
• Wang N, Lu S, Cao Z, Li H, Xu J, Zhou Q, Yin H, Qian Q, Zhang X, Tao M, Jiang Q, Zhou P, Zheng L, Han L, Li H, Yin L, Gu Y, Dou X, Sun H, Wang W, Piao HL, Li F, Xu Y, Yang W, Chen S, Liu J. Pyruvate metabolism enzyme DLAT promotes tumorigenesis by suppressing leucine catabolism. Cell Metab. 2025 Jun 3;37(6):1381-1399.e9. doi: 10.1016/j.cmet.2025.02.008. Epub 2025 Mar 19. PMID 40112809

Identifiers

NCT: NCT07488312 · KYLL-2025-07-007-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗