Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer
NCT ID: NCT04264676
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
294 participants
INTERVENTIONAL
2020-03-31
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Metronidazole
supplement of metronidazole 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6(6 treatments totally),and every 6 weeks for CapeOX (4 treatments totally).
Metronidazole Oral Tablet
Supplement of metronidazole 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
Placebo
supplement of identical-appearing placebo 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6 (6 treatments totally),and every 6 weeks for CapeOX 4 treatments totally).
Placebo oral tablet
Supplement of placebo oral tablet 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
Interventions
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Metronidazole Oral Tablet
Supplement of metronidazole 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
Placebo oral tablet
Supplement of placebo oral tablet 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Municipal Commission of Health and Family Planning
OTHER
Ruijin Hospital
OTHER
Fudan University
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai Shenkang Hospital Development Center
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jing-yuan Fang, MD, Ph. D
Director of Department of Gastroenterology
Principal Investigators
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Jingyuan Fang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health
Shanghai, Shanghai Municipality, China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jing-Yuan Fang, MD. Ph D.
Role: primary
Yan Shi, MD. Ph D.
Role: primary
Sanjun Cai, MD. Ph D.
Role: primary
Jianyong Sun, MD. Ph D.
Role: primary
Other Identifiers
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KY2019-066
Identifier Type: -
Identifier Source: org_study_id