Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Mar 27, 2025
  • participants needed
    294
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 27 January 2021

Summary

Fusobacterium nucleatum (Fusobacterium nucleatum, Fn) has been identified as an independent risk factor for recurrence of colorectal cancer. In this study, oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.

Description

Gut microbiota are linked to chronic inflammation and carcinogenesis. Chemotherapy failure is the major cause of recurrence and poor prognosis in colorectal cancer patients. Previously in the investigators' research, the investigators find the contribution of gut microbiota to chemoresistance in patients with colorectal cancer. The investigators found that Fusobacterium nucleatum (Fn) was abundant in colorectal cancer tissues in patients with recurrence post chemotherapy, and was associated with patient clinicopathological characterisitcs. Furthermore, the investigators' bioinformatic and functional studies demonstrated that Fn promoted colorectal cancer resistance to chemotherapy. Metronidazole has been known to treat with anaerobe infection, including Fusobacterium. So oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.

Details
Condition Stage III Colorectal Cancer, Colorectal Cancer Stage III, Colorectal Cancer Stage II
Treatment Placebo Oral Tablet, Metronidazole Oral Tablet
Clinical Study IdentifierNCT04264676
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals aged 18-75 years
Individuals firstly confirmed by surgery pathology as colorectal cancer (AJCC cancer staging II - III), who need mFOLFOX6 or CapeOX postoperative chemotherapy
Individuals with Fn - deltaCT value in colon tissue samples detected by qPCR -12 before receiving chemotherapy
Individuals who could tolerate chemotherapy drugs: ECOG (Eastern Cooperative Oncology Group) score 2 points, WBC(White Blood Cell) 4.010^9/L, Hb Hemoglobin 80g/L, PLT Platelet 8010^9/L, ALT Alanine Aminotransferase< 2ULN Upper Limmit of Normal, Scr Creatinine< 1.5ULN
Individuals who participate this study and sign the informed consent form willingly

Exclusion Criteria

Individuals with colorectal adenoma or non-colorectal cancer, such as inflammatory bowel disease
Individuals with a history of familial adenomatous polyposis (FAP)
Individuals with severe heart, lung, brain, kidney, gastrointestinal or systemic diseases
Individuals who used antibiotics for more than 5 days in 1 month prior to chemotherapy
Individuals with stage I or IV colorectal cancer, or with stage II colorectal cancer who do not need postoperative chemotherapy
Individuals with contraindications for metronidazole
Individuals who unwilling to participate this studyor unwilling to sign the informed consent form
Individuals with any conditions that the researchers considered inappropriate for inclusion
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