Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
- Conditions
- Gastric CancerNeoadjuvant Chemotherapy
- Interventions
- Registration Number
- NCT05901779
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT.
Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 318
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Group live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules PG (probiotic group) patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. The intervention begins from the completion of preoperative chemotherapy to the seventh day after surgery.
- Primary Outcome Measures
Name Time Method postoperative infectious complications up tp 30 days after surgery The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.
- Secondary Outcome Measures
Name Time Method postoperative recovery parameter up tp 30 days after surgery time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;
postoperative death and readmission up tp 30 days after surgery postoperative death and readmission within 30 days after surgery
duration of therapeutic antibiotic use up tp 30 days after surgery duration of therapeutic antibiotic use measured as "day"
time to postoperative adjuvant chemotherapy up tp 30 days after surgery durition from surgery to postoperative adjuvant chemotherapy.
European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0) on postoperative day 30 The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30, Higher scores for functional areas and general health indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or medical problems. The minimum value is 0 and maximum value is 100.
Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 on postoperative day 3, 5, and 30 Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100
visual analogue scale on postoperative day 1, 3 and 5 from minimum 0 to maximun 10, higher score means more pain.
Leukocyte Count Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "\*10\^9/L", recorded respectively according to measure time
percent of neutrophile granulocyte Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "%", recorded respectively according to measure time
procalcitonin Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "pg/ml", recorded respectively according to measure time
C-reactive protein Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "mg/L", recorded respectively according to measure time
albumin Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "\*g/L", recorded respectively according to measure time
prealbumin Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "mg/L", recorded respectively according to measure time
total bilirubin Postoperative, on postoperative day 1, 3 and 5 unit of measurement is "μmol/L", recorded respectively according to measure time
Trial Locations
- Locations (1)
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
🇨🇳Qingdao, Shandong, China