Back to resultsThe Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
Primary Purpose
Gastric Cancer, Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
adjuvant chemotherapy
Sponsored by
About this trial
This is an interventional other trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years old, male or female
- Surgery specimens were clearly diagnosed as gastric cancer and colon cancer by histopathology
- The operation method is not limited (both laparoscopic surgery and open surgery)
- After the perioperative period, stop using antibiotics for not less than 2 weeks
- It is planned to receive a chemotherapy regimen with a combination of platinum and fluorouracil for a period of 21 days (gastric cancer is the SOX or XELOX regimen, and colon cancer is the XELOX or FOLFOX regimen)
- Blood routine, biochemical and other related laboratory tests showed no obvious abnormalities
- There are no contraindications for related adjuvant chemotherapy indications.
Exclusion Criteria:
- Neoadjuvant treatment before gastric and bowel cancer surgery
- Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
- Before the perioperative period, because of anastomotic fistula and gastrointestinal perforation, reoperation
The following drugs were used within 2 weeks before enrollment:
- Various antibiotics, including antifungals (oral and intravenous)
- Probiotic preparations, various prebiotic preparations, etc c Glucocorticoids; d Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.)
- Other situations that the researcher considers unsuitable to participate in the experiment;
Sites / Locations
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
Outcomes
Primary Outcome Measures
The change of diversity of intestinal flora in faeces during chemotherapy
The change of diversity of urethral flora in urine during chemotherapy
The change of abundance of intestinal flora in faeces during chemotherapy
The change of abundance of urethral flora in urine during chemotherapy
The change of concentration of purine metabolites in urine during chemotherapy
The change of concentration of P-hydroxyphenylalanine metabolites in urine during chemotherapy
Secondary Outcome Measures
The change of the number of Gastrin in blood during chemotherapy
The change of the number of CD4+T cell and CD8+T cell in blood during chemotherapy chemotherapy
The change of the number of Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6, in blood during chemotherapy
The change of the number of tumor necrosis factor(TNF)-α in blood during chemotherapy
Full Information
NCT ID
NCT04198051
First Posted
December 3, 2019
Last Updated
December 11, 2019
Sponsor
The First Affiliated Hospital of Dalian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04198051
Brief Title
The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
Official Title
The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Anticipated)
Primary Completion Date
December 20, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. The intestinal flora affects the body's nutrition, immunity and metabolism through interaction with the human body and the external environment, and is closely related to multiple systems. When the flora structure and function are changed, it will lead to the occurrence of various diseases or increase the risk of disease. In recent years, the role of intestinal microbes in tumorigenesis and development, as well as the role of diagnosis and treatment have been paid more and more attention. Abnormal intestinal flora can not only promote tumorigenesis, but also affect radiochemotherapy and immunotherapy effects. It is worth noting that the huge impact of the intestinal flora on immunotherapy suggests that immune checkpoint inhibitors can maximize the efficacy by protecting the balance and diversity of the intestinal microecology. Therefore, in this study, quantitative analysis of the diversity and abundance of intestinal, urinary tract flora, and urine components before and after adjuvant chemotherapy in patients with gastric and bowel cancer was performed. The link between treatment efficacy and prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colon Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy
Intervention Description
Form、dosage and frequency： Gastric cancer was given the SOX regimen (oxaliplatin + tegafur regimen,oxaliplatin 130mg/m2 intravenous infusion, the 1st day; tegafur 80mg/ m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle) or XELOX regimen (oxaliplatin + capecitabine regimen，oxaliplatin 130mg/m2 intravenous infusion, the 1st day; capecitabine 1000mg/m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle).
Colon cancer was given the XELOX regimen (the dosage、frequency and administration are the same as the gastric cancer) or FOLFOX regimen (oxaliplatin + calcium folinate + fluorouracil regimen，oxaliplatin 85mg/m2 intravenous infusion, the 1st day; calcium folinate 400 mg/m2 intravenous infusion, the 1st day; fluorouracil 400 mg/m2 intravenous infusion, the 1st day, then 1200 mg/m2/d × 2d continuous intravenous infusion，every 14 days is one cycle).
Duration：through chemotherapy completion，about six months.
Primary Outcome Measure Information:
Title
The change of diversity of intestinal flora in faeces during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Title
The change of diversity of urethral flora in urine during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Title
The change of abundance of intestinal flora in faeces during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Title
The change of abundance of urethral flora in urine during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Title
The change of concentration of purine metabolites in urine during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Title
The change of concentration of P-hydroxyphenylalanine metabolites in urine during chemotherapy
Time Frame
The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Secondary Outcome Measure Information:
Title
The change of the number of Gastrin in blood during chemotherapy
Time Frame
the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
Title
The change of the number of CD4+T cell and CD8+T cell in blood during chemotherapy chemotherapy
Time Frame
the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
Title
The change of the number of Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6, in blood during chemotherapy
Time Frame
the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
Title
The change of the number of tumor necrosis factor(TNF)-α in blood during chemotherapy
Time Frame
the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years old, male or female
Surgery specimens were clearly diagnosed as gastric cancer and colon cancer by histopathology
The operation method is not limited (both laparoscopic surgery and open surgery)
After the perioperative period, stop using antibiotics for not less than 2 weeks
It is planned to receive a chemotherapy regimen with a combination of platinum and fluorouracil for a period of 21 days (gastric cancer is the SOX or XELOX regimen, and colon cancer is the XELOX or FOLFOX regimen)
Blood routine, biochemical and other related laboratory tests showed no obvious abnormalities
There are no contraindications for related adjuvant chemotherapy indications.
Exclusion Criteria:
Neoadjuvant treatment before gastric and bowel cancer surgery
Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
Before the perioperative period, because of anastomotic fistula and gastrointestinal perforation, reoperation
The following drugs were used within 2 weeks before enrollment:
Various antibiotics, including antifungals (oral and intravenous)
Probiotic preparations, various prebiotic preparations, etc c Glucocorticoids; d Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.)
Other situations that the researcher considers unsuitable to participate in the experiment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
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