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

The Affiliated Hospital of Qingdao University1 site in 1 country90 target enrollmentJune 1, 2024

ConditionsGastric Cancer Prehabilitation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: The Affiliated Hospital of Qingdao University
Enrollment: 90
Locations: 1
Primary Endpoint: Cardiopulmonary capacity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

May 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Affiliated Hospital of Qingdao University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged ≥18 years;
•Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
•Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
•The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
•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;
•The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
•Informed consent and ability to comply with research protocols.

Exclusion Criteria

•metastasis;
•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;
•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;
•Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
•Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
•Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
•Patients participating in other clinical trials.

Outcomes

Primary Outcomes

Cardiopulmonary capacity

Time Frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.

Secondary Outcomes

Patient's quality of life(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
Serum albumin levels(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
First liquid diet(Postoperative (≤30 days after surgery))
3-year overall survival(3 years)
sarcopenia(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
Duration of postoperative hospital stay(Postoperative (≤30 days after surgery))
3-year recurrence-free survival(3 years)
First exhaust and defecation(Postoperative (≤30 days after surgery))
The incidence of postoperative complications(Postoperative (≤30 days after surgery))
completetion of neoadjuvant chemotherapy(Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks))
Hospitalization costs(Postoperative (≤30 days after surgery))