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

NCT ID: NCT06521541

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-01

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.

Conditions

Gastric Cancer; Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multimodal prehabilitation group

Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.

Group Type: EXPERIMENTAL

Multimodal prehabilitation program

Intervention Type: BEHAVIORAL

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

ERAS group

The ERAS pathway was followed in patients in the ERAS group.

Group Type: ACTIVE_COMPARATOR

ERAS program

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanbing Zhou

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanbing Zhou, MD

Role: CONTACT

zhouyanbing@qduhospital.cn

86532-82911324

Qi Liu

Role: CONTACT

lq112867@163.com

86532-82911324

Facility Contacts

Yanbing Zhou, MD

Role: primary

zhouyanbing@qduhospital.cn

86532-82911324

Other Identifiers

Prehab2024-01

Identifier Type: -

Identifier Source: org_study_id