Clinical trial · Interventional
Effect of Exercise and Enteral Nutrition on Survival
Effect of Exercise and Enteral Nutrition Intervention on Survival in Patients With Locally Advanced Gastric Cancer: a Prospective Multicenter Randomized Controlled Study
NCT05959226CI-TRIAL-00068255ENERGYnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Nutrition Related Cancer | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Nutrition Intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and Enteral Nutrition Intervention
- description
- A comprehensive postoperative management combined physical exercise intervention with oral nutritional support
- interventionNames
- Behavioral: Exercise Intervention
- Dietary Supplement: Nutrition Intervention
- type
- ACTIVE_COMPARATOR
- label
- Enteral Nutrition Intervention
- description
- The control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.
- interventionNames
- Dietary Supplement: Nutrition Intervention
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:(1) 18 years ≤ age ≤ 70 years (2) Preoperative Karnofsky physical condition score: 0 or 1 or 2 (3) Preoperative pathological biopsy by gastroscope, histologically confirmed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma) (4) Gastric cancer patients diagnosed with clinical stage Ib IIIc through CT, MRI, gastroscopy, and pathology (based on the 8th edition of UICC/AJCC staging) (5) Abdominal enhanced CT/MRI examination showed a clinical staging of cT2-4aN0-3M0 (based on AJCC-8thTNM tumor staging), and standard D2 radical surgery for gastric cancer was performed; (6) Have not received any radiotherapy, chemotherapy or immunotherapy; (7) Hemoglobin ≥ 80g/L; (8) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; (9) Platelets ≥ 75 × 109/L; (10) ALT ≤ 2.5 times the normal upper limit value; (11) AST ≤ 2.5 times the normal upper limit value; (12) ALP ≤ 2.5 times the normal upper limit value; (13) Serum total bilirubin\<1.5 times the upper normal limit value; (14) Serum creatinine\<1 times the upper normal limit value; (15) Sign written informed consent; Exclusion Criteria: 1. Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT 2. Pregnant or lactating women 3. People with uncontrolled epilepsy, Central nervous system disease or mental disorders 4. Patients with combined limb disabilities or motor dysfunction; 5. Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ 6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 6 months 7. Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months 8. Organ transplantation requires immunosuppressive therapy 9. Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases 10. The patient has complications of Grade III or above in Clavien Dindo classification or has been hospitalized for more than 14 days after surgery due to various reasons; 11. Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction) 12. Pulmonary function test FEV1\<expected value 50% 13. Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery
References
Publications (5)
- BACKGROUNDTegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31. PMID 26331988
- BACKGROUNDYu 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
- BACKGROUNDDavis 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
- BACKGROUNDCliment M, Munarriz M, Blazeby JM, Dorcaratto D, Ramon JM, Carrera MJ, Fontane L, Grande L, Pera M. Weight loss and quality of life in patients surviving 2 years after gastric cancer resection. Eur J Surg Oncol. 2017 Jul;43(7):1337-1343. doi: 10.1016/j.ejso.2017.01.239. Epub 2017 Feb 9. PMID 28222970
- BACKGROUNDAoyama T, Sato T, Maezawa Y, Kano K, Hayashi T, Yamada T, Yukawa N, Oshima T, Rino Y, Masuda M, Ogata T, Cho H, Yoshikawa T. Postoperative weight loss leads to poor survival through poor S-1 efficacy in patients with stage II/III gastric cancer. Int J Clin Oncol. 2017 Jun;22(3):476-483. doi: 10.1007/s10147-017-1089-y. Epub 2017 Feb 7. PMID 28176023