Prehabilitation program for patients with gastric cancer before surgery

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

This study tests a special health program for people with gastric cancer to see if it helps them get stronger and healthier before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT06521541 on ClinicalTrials.gov

What this trial studies

This research aims to implement a multimodal prehabilitation protocol for patients undergoing neoadjuvant chemotherapy prior to gastrectomy. The study will assess the feasibility and effectiveness of this program, focusing on its impact on short-term clinical outcomes, physical fitness, and long-term prognosis. Participants will receive a structured prehabilitation regimen designed to optimize their health before surgery. The study will evaluate various health metrics to determine the program's success.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed gastric adenocarcinoma who are eligible for neoadjuvant chemotherapy and subsequent gastrectomy.

Not a fit: Patients with metastatic disease or severe comorbidities that contraindicate surgery or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and improve clinical outcomes for patients undergoing surgery for gastric cancer.

How similar studies have performed: While multimodal prehabilitation is a growing area of interest, this specific approach in the context of gastric cancer and neoadjuvant treatment is relatively novel.

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.

Where this trial is running

Qingdao, Shandong

• Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yanbing Zhou, MD

Conditions Gastric Cancer; Prehabilitation; Multimodal prehabilitation; Neoadjuvant chemotherapy