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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Prehabilitation
• Intervention / Treatment: Behavioral: Multimodal prehabilitation program; Behavioral: ERAS program

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn
• Study Contact Backup: Name: Qi Liu; Phone Number: 86532-82911324; Email: lq112867@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
      • Contact: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal prehabilitation group; Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.	Behavioral: Multimodal prehabilitation program; Patients adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.Patients were evaluated for changes during neoadjuvant therapy and postoperative recovery
Active Comparator: ERAS group; The ERAS pathway was followed in patients in the ERAS group.	Behavioral: ERAS program; The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary capacity	The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's quality of life	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.	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Serum albumin levels	The level of Serum albumin is used to assess nurtritional status.	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
sarcopenia	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.	Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
completetion of neoadjuvant chemotherapy	Discontinued due to adverse reactions	Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)
First exhaust and defecation	First exhaust and defecation is used to assess the postoperative recovery course.	Postoperative (≤30 days after surgery)
First liquid diet	First liquid diet is used to assess the postoperative recovery course.	Postoperative (≤30 days after surgery)
The incidence of postoperative complications	Refers to the incidence of early postoperative complications.	Postoperative (≤30 days after surgery)
Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	Postoperative (≤30 days after surgery)
Hospitalization costs	The expense from admission to discharge	Postoperative (≤30 days after surgery)
3-year recurrence-free survival	3-year recurrence-free survival (RFS) rate	3 years
3-year overall survival	3-year overall survival (OS) rate	3 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Director: Yanbing Zhou, The Affiliated Hospital Of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; Multimodal prehabilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Prehab2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No