Probiotics for gastric cancer patients undergoing chemotherapy
Effect of Perioperative Probiotic Supplements on Postoperative Short-term Outcomes in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: A Prospective, Randomized, Controlled, Multicenter Clinical Trial
This study is testing if taking probiotic supplements can help gastric cancer patients undergoing chemotherapy have fewer infections and better recovery after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT05901779 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of probiotic supplements on patients with gastric cancer who are receiving neoadjuvant chemotherapy. It is a multicentre randomized controlled trial that divides participants into two groups: one receiving probiotics and the other receiving a placebo. The aim is to assess whether probiotics can reduce postoperative infections and improve short-term outcomes after surgery. The study will include patients aged 18-80 with confirmed gastric adenocarcinoma who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed gastric adenocarcinoma who are scheduled to receive neoadjuvant chemotherapy.
Not a fit: Patients requiring emergency surgery, those with recent antibiotic use, or individuals with certain infections or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for gastric cancer patients undergoing chemotherapy.
How similar studies have performed: While previous studies have suggested potential benefits of probiotics in reducing postoperative complications, this is one of the first large-scale, multicentre trials specifically targeting gastric cancer patients receiving neoadjuvant chemotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-80 years old * male and female * clinical stage was T3/4N+ evaluated by CT/MR/EUS at new diagnosis (before any anti-cancer treatment) , complete 2-4 cycles preoperative chemotherapy based on 5-FU (such as SOX, FLOX, ect.) at 3-6 weeks before surgery * ASA grade was Ⅰ\~Ⅲ * radical minimal-invasive gastrectomy via laparoscope or DaVinci is judged as possible * histologically confirmed gastric adenocarcinoma * ECOG score is 0\~1 * patients who provide a written informed consent before entering study screening Exclusion Criteria: * need emergency surgery due to performation and/or obstruction * receive antibiotics and/or glucocorticoids within 14 days before surgery * exist bacterial infection and/or autoimmune disease and/or IBD currently * intolerance or allergic to probiotics * upper abdominal surgery history * use probiotics within 7 days before intervention, such as yogurt, ect. * participate in other clinical trials currently * severe mental illness * can not participate in this trial due to severe illness of other organs evaluated by researchers, such as severe cardiac insufficiency (LVEF\<30%, NYHA\>Ⅱ, severe arrhythmia, congestive heart failure, myocardial infarction within 6 months), liver dysfunction (Child-Pugh C), renal dysfunction (need hemodialysis) * need simultaneous surgery * lactation or pregnancy * refuse to participate in this trial
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
- Email: zhouyanbing@qduhospital.cn
- Phone: 86532-82911324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.