Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

About this trial

This is an interventional prevention trial for Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Gastrointestinal Surgery, Qingdao University Affiliated HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotic Group

Control Group

Arm Description

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.

CG (Control Group) patients receive blank control management.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

postoperative recovery parameter

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

postoperative death and readmission

postoperative death and readmission within 30 days after surgery

duration of therapeutic antibiotic use

duration of therapeutic antibiotic use measured as "day"

time to postoperative adjuvant chemotherapy

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)

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

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

visual analogue scale

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

Leukocyte Count

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

percent of neutrophile granulocyte

unit of measurement is "%", recorded respectively according to measure time

procalcitonin

unit of measurement is "pg/ml", recorded respectively according to measure time

C-reactive protein

unit of measurement is "mg/L", recorded respectively according to measure time

albumin

unit of measurement is "*g/L", recorded respectively according to measure time

prealbumin

unit of measurement is "mg/L", recorded respectively according to measure time

total bilirubin

unit of measurement is "μmol/L", recorded respectively according to measure time

Full Information

NCT ID

NCT05901779

First Posted

May 8, 2023

Last Updated

June 4, 2023

Sponsor

The Affiliated Hospital of Qingdao University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05901779

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Affiliated Hospital of Qingdao University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Neoadjuvant Chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

318 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

CG (Control Group) patients receive blank control management.

Intervention Type

Drug

Intervention Name(s)

live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative infectious complications

Description

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 Outcome Measure Information:

Title

postoperative recovery parameter

Description

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

Time Frame

up tp 30 days after surgery

Title

postoperative death and readmission

Description

postoperative death and readmission within 30 days after surgery

Time Frame

up tp 30 days after surgery

Title

duration of therapeutic antibiotic use

Description

duration of therapeutic antibiotic use measured as "day"

Time Frame

up tp 30 days after surgery

Title

time to postoperative adjuvant chemotherapy

Description

durition from surgery to postoperative adjuvant chemotherapy.

Time Frame

up tp 30 days after surgery

Title

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

Description

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

Title

Postgastrectomy Syndrome Assessment Scale (PGSAS)-45

Description

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

Title

visual analogue scale

Description

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

Time Frame

on postoperative day 1, 3 and 5

Title

Leukocyte Count

Description

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

Time Frame