Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901779
• Other study ID #: GISSG2023-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yanbing Zhou, MD
• Phone: 86532-82911324
• Email: zhouyanbing[@]qduhospital.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?~?
• 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>?, 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

Related Conditions & MeSH terms

• Gastric Cancer
• Neoadjuvant Chemotherapy
• Stomach Neoplasms

Intervention

Drug:
• live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Probiotics capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. Each capsule contained>10,000,000 colony-forming units (CFUs). This drug can treat endoxemia caused by imbalance of intestinal flora.

Locations

Country	Name	City	State
China	Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital	Qingdao	Shandong

Sponsors (20)

Lead Sponsor

Collaborator

The Affiliated Hospital of Qingdao University

Binzhou Medical University, Binzhou People's Hospital, Dongying People's Hospital, Jinan Central Hospital, Liaocheng People's Hospital, Qianfoshan Hospital, Qilu Hospital of Shandong University, Qingdao Municipal Hospital, Rizhao People's Hospital, Shandong Cancer Hospital and Institute, Shandong Jining No.1 People's Hospital, Shandong Provincial Hospital, The People's Hospital of Jimo.Qingdao, The Second Hospital of Shandong University, Weifang Medical University, Weifang People's Hospital, Weihai Central Hospital, Weihai Municipal Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up tp 30 days after surgery
Secondary	postoperative recovery parameter	time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;	up tp 30 days after surgery
Secondary	postoperative death and readmission	postoperative death and readmission within 30 days after surgery	up tp 30 days after surgery
Secondary	duration of therapeutic antibiotic use	duration of therapeutic antibiotic use measured as "day"	up tp 30 days after surgery
Secondary	time to postoperative adjuvant chemotherapy	durition from surgery to postoperative adjuvant chemotherapy.	up tp 30 days after surgery
Secondary	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.	on postoperative day 30
Secondary	Postgastrectomy Syndrome Assessment Scale (PGSAS)-45	Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100	on postoperative day 3, 5, and 30
Secondary	visual analogue scale	from minimum 0 to maximun 10, higher score means more pain.	on postoperative day 1, 3 and 5
Secondary	Leukocyte Count	unit of measurement is "*10^9/L", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	percent of neutrophile granulocyte	unit of measurement is "%", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	procalcitonin	unit of measurement is "pg/ml", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	C-reactive protein	unit of measurement is "mg/L", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	albumin	unit of measurement is "*g/L", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	prealbumin	unit of measurement is "mg/L", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5
Secondary	total bilirubin	unit of measurement is "µmol/L", recorded respectively according to measure time	Postoperative, on postoperative day 1, 3 and 5