The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer

NCT04198051 | Unknown

• 1 other identifier: PJ-KY-2019-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (6)

• The change of diversity of intestinal flora in faeces during chemotherapy

  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.

• The change of diversity of urethral flora in urine during chemotherapy

  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.

• The change of abundance of intestinal flora in faeces during chemotherapy

  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.

• The change of abundance of urethral flora in urine during chemotherapy

  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.

• The change of concentration of purine metabolites in urine during chemotherapy

  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.

• The change of concentration of P-hydroxyphenylalanine metabolites in urine during chemotherapy

  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 Outcomes (4)

• The change of the number of Gastrin in blood during chemotherapy

  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.

• The change of the number of CD4+T cell and CD8+T cell in blood during chemotherapy chemotherapy

  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.

• The change of the number of Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6, in blood during chemotherapy

  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.

• The change of the number of tumor necrosis factor(TNF)-α in blood during chemotherapy

  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.

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: adjuvant chemotherapy

Interventions

adjuvant chemotherapy DRUG

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Xiaonan Cui, MD,PhD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaonan Cui, MD,PhD

CONTACT

+8618098876725; cxn23@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 13, 2019
• Study Start: December 20, 2019
• Primary Completion: December 20, 2020
• Study Completion: May 1, 2021
• Last Updated: December 13, 2019

Record last verified: 2019-09

Locations

CN (1)