Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

The Affiliated Hospital of Qingdao University318 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

318

Conditions

Gastric Cancer Neoadjuvant Chemotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

postoperative infectious complications

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.

Time frame: up tp 30 days after surgery

Secondary Outcomes

postoperative recovery parameter

time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;

Time frame: up tp 30 days after surgery

postoperative death and readmission

postoperative death and readmission within 30 days after surgery

Time frame: up tp 30 days after surgery

duration of therapeutic antibiotic use

duration of therapeutic antibiotic use measured as "day"

Time frame: up tp 30 days after surgery

time to postoperative adjuvant chemotherapy

durition from surgery to postoperative adjuvant chemotherapy.

Time frame: up tp 30 days after surgery

European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0)

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.

Time frame: on postoperative day 30

Postgastrectomy Syndrome Assessment Scale (PGSAS)-45

Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100

Time frame: on postoperative day 3, 5, and 30

visual analogue scale

from minimum 0 to maximun 10, higher score means more pain.

Time frame: on postoperative day 1, 3 and 5

Leukocyte Count

unit of measurement is "\*10\^9/L", recorded respectively according to measure time