Clinical trial NCT05959226: Effect of Exercise and Enteral Nutrition on Survival
Official title: Effect of Exercise and Enteral Nutrition Intervention on Survival in Patients With Locally Advanced Gastric Cancer: a Prospective Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Nutrition Related Cancer
Sarcopenia
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The present clinical trial was designed to explore the effect of physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer. In the trial group, comprehensive postoperative management model with targeted exercise intervention and nutritional support. The details are as follows:

1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of enteral nutrition supplement (ONS) in addition to their normal diet. Once the patient's oral diet decreases, ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcal/kg. The daily protein requirement is set at 1.2-1.5 g/kg of actual body weight. The Dietitian will keep records and help patients adjust their energy intake weekly.
2. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week; The control group patients received the same baseline evaluation as the experimental group patients. The control group will not receive phisical exercise intervention, but will receive postoperative nutritional treatment with the same standards as the experimental group.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year overall survival rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: 3-year disease-free survival rate
timeFrame: 3 years after surgery
measure: Scored Patient-Generated Subjective Global Assessment, PG-SGA
timeFrame: 6 months after surgery
measure: QLQ-C30 assessment
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.
citation: Climent 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.
citation: Aoyama 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.