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

Not Applicable

Recruiting

• Conditions: Gastric Cancer; Prehabilitation
• Interventions: Behavioral: ERAS program; Behavioral: Multimodal prehabilitation program

• Registration Number: NCT06521541
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS program	The ERAS pathway was followed in patients in the ERAS group.
Multimodal prehabilitation group	Multimodal prehabilitation program	Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary capacity	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 Outcome Measures

Name	Time	Method
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)	QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.
Serum albumin levels	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)	The level of Serum albumin is used to assess nurtritional status.
First liquid diet	Postoperative (≤30 days after surgery)	First liquid diet is used to assess the postoperative recovery course.
sarcopenia	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)	At the L3 level, total SM will be measured. Skeletal muscle index (SMI) will be calculated as follows: SM/height(m)2. SMI is used to assess nurtritional status.
Duration of postoperative hospital stay	Postoperative (≤30 days after surgery)	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
3-year recurrence-free survival	3 years	3-year recurrence-free survival (RFS) rate
3-year overall survival	3 years	3-year overall survival (OS) rate
First exhaust and defecation	Postoperative (≤30 days after surgery)	First exhaust and defecation is used to assess the postoperative recovery course.
The incidence of postoperative complications	Postoperative (≤30 days after surgery)	Refers to the incidence of early postoperative complications.
completetion of neoadjuvant chemotherapy	Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)	Discontinued due to adverse reactions
Hospitalization costs	Postoperative (≤30 days after surgery)	The expense from admission to discharge

Trial Locations

Locations (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital; 🇨🇳 Qingdao, Shandong, China