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Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy | Clinical Trials | Clareo Health

RECRUITINGNA

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial

NCT06521541•The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years;
•2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
•3. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
•4. The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
•5. Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery;
•6. The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
•7. Informed consent and ability to comply with research protocols.

Exclusion Criteria

•1. metastasis;
•2. End-stage cardiac insufficiency (LVEF\<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
•3. Cerebral hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise;
•4. Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
•5. Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
•6. Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
•7. Patients participating in other clinical trials.

Locations (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Key Dates

Start Date

June 1, 2024

Primary Completion Date

January 1, 2025

Completion Date

May 1, 2025

Last Updated

July 26, 2024

Enrollment

ESTIMATED participants

Conditions

Gastric CancerPrehabilitation

Interventions

Multimodal prehabilitation program

BEHAVIORAL

ERAS program

BEHAVIORAL

Contacts

Yanbing Zhou, MD

CONTACT

86532-82911324 zhouyanbing@qduhospital.cn

Qi Liu

CONTACT

86532-82911324 lq112867@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy

Inclusion Criteria

Exclusion Criteria

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