Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Fudan University; Ruijin Hospital; Shanghai Municipal Commission of Health and Family Planning; Shanghai Shenkang Hospital Development Center; Shanghai Zhongshan Hospital
• Treatments: Metronidazole

Criteria

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) ≥4.0×10^9/L, Hb （Hemoglobin） ≥80g/L, PLT （Platelet） ≥80×10^9/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 study，or unwilling to sign the informed consent form

• Individuals with any conditions that the researchers considered inappropriate for inclusion