Clinical trial NCT05901779: Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Effect of Perioperative Probiotic Supplements on Postoperative Short-term Outcomes in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: A Prospective, Randomized, Controlled, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Neoadjuvant Chemotherapy
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Qianfoshan Hospital
name: Shandong Provincial Hospital
name: Yantai Yuhuangding Hospital
name: Jining First People's Hospital
name: Weifang Medical University
name: Weifang People's Hospital
name: Dongying People's Hospital
name: Weihai Municipal Hospital
name: Weihai Central Hospital
name: Rizhao People's Hospital
name: Liaocheng People's Hospital
name: Qingdao Municipal Hospital
name: The Second Hospital of Shandong University
name: The People's Hospital of Jimo.Qingdao
name: Binzhou People's Hospital
name: Binzhou Medical University
name: Jinan Central Hospital
name: Shandong Cancer Hospital and Institute
First posted: 2023-06-13
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: postoperative infectious complications
timeFrame: up tp 30 days after surgery
Secondary outcomes:
measure: postoperative recovery parameter
timeFrame: up tp 30 days after surgery
measure: postoperative death and readmission
timeFrame: up tp 30 days after surgery
measure: duration of therapeutic antibiotic use
timeFrame: up tp 30 days after surgery
measure: time to postoperative adjuvant chemotherapy
timeFrame: up tp 30 days after surgery
measure: European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0)
timeFrame: on postoperative day 30
measure: Postgastrectomy Syndrome Assessment Scale (PGSAS)-45
timeFrame: on postoperative day 3, 5, and 30
measure: visual analogue scale
timeFrame: on postoperative day 1, 3 and 5
measure: Leukocyte Count
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: percent of neutrophile granulocyte
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: procalcitonin
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: C-reactive protein
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: albumin
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: prealbumin
timeFrame: Postoperative, on postoperative day 1, 3 and 5
measure: total bilirubin
timeFrame: Postoperative, on postoperative day 1, 3 and 5
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yanbing Zhou, MD
role: STUDY_DIRECTOR
References: