NCT05959226

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
27mo left

Started Aug 2023

Longer than P75 for not_applicable gastric-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2023Aug 2028

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

July 17, 2023

Last Update Submit

July 17, 2023

Conditions

Gastric CancerNutrition Related CancerSarcopenia

Outcome Measures

Primary Outcomes (1)

  • 3-year overall survival rate

    The 3-year overall survival rate refers to the proportion of gastric cancer patients who have survived for more than 3 years after various comprehensive treatments

    3 years after surgery

Secondary Outcomes (3)

  • 3-year disease-free survival rate

    3 years after surgery

  • Scored Patient-Generated Subjective Global Assessment, PG-SGA

    6 months after surgery

  • QLQ-C30 assessment

    6 months after surgery

Study Arms (2)

Exercise and Enteral Nutrition Intervention

EXPERIMENTAL

A comprehensive postoperative management combined physical exercise intervention with oral nutritional support

Behavioral: Exercise InterventionDietary Supplement: Nutrition Intervention

Enteral Nutrition Intervention

ACTIVE COMPARATOR

The control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.

Dietary Supplement: Nutrition Intervention

Interventions

Exercise InterventionBEHAVIORAL

1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet.. 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;

Exercise and Enteral Nutrition Intervention
Nutrition InterventionDIETARY_SUPPLEMENT

(1) Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet..

Enteral Nutrition InterventionExercise and Enteral Nutrition Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT
  • Pregnant or lactating women
  • People with uncontrolled epilepsy, Central nervous system disease or mental disorders
  • Patients with combined limb disabilities or motor dysfunction;
  • Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ
  • 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
  • Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months
  • Organ transplantation requires immunosuppressive therapy
  • Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases
  • 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;
  • Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction)
  • Pulmonary function test FEV1\<expected value 50%
  • Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Tegels 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: 26331988BACKGROUND

  • 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: 31135850BACKGROUND

  • 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: 26732274BACKGROUND

  • 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.

    PMID: 28222970BACKGROUND

  • 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.

    PMID: 28176023BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsSarcopenia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Quan Wang, Dr

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingjie Xia, Dr

CONTACT

86-431-81875601xmj1983@jlu.edu.cn

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
Professor

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2028

Last Updated

July 25, 2023

Record last verified: 2023-07