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

NCT06521541 | Recruiting DMC

• 1 other identifier: Prehab2024-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Multimodal prehabilitation; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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)

• sarcopenia

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

• completetion of neoadjuvant chemotherapy

  Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)

• First exhaust and defecation

  Postoperative (≤30 days after surgery)

Study Arms (2)

Multimodal prehabilitation group

EXPERIMENTAL

Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.

Behavioral: Multimodal prehabilitation program

ERAS group

ACTIVE COMPARATOR

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

Behavioral: ERAS program

Interventions

Multimodal prehabilitation program 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

Multimodal prehabilitation group

ERAS program 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.

ERAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yanbing Zhou

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Yanbing Zhou, MD

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Qi Liu

CONTACT

86532-82911324; lq112867@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 26, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)