Chemotherapy-induced diarrhea
Conditions
Interventions
Berberine group:Oral Berberine
Placebo group:Oral placebo
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients with high-risk stage III and stage IV colorectal cancer who are expected to successfully complete a 6-month chemotherapy regimen. Eligible chemotherapy regimens included FOLFIRI, FOLFOX, XELOX, FOLFOXIRI, mXELIRI and CapIRI. (2) Age 18 to 80 years. (3) ECOG score =1. (4) Patients have good compliance and voluntarily receive follow-up, treatment, laboratory tests and other research steps as planned. (5) Patients or family members can understand the research plan and are willing to participate in the study, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Taking non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and probiotics on a regular basis. (2) IBD; pelvic radiation concurrent with chemotherapy; without a functioning rectum after surgeries. (3) Severe heart, liver or kidney disease; with a history of other malignancies. (4) Psychiatric patients and patients who are unable to communicate verbally. (5) Patients who are allergic or intolerant to the berberine. (6) Female patients who are pregnant, breastfeeding, planning a pregnancy. (7) Severe constipation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CID from 1 to 6 months (grade =3); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of CID from 1 to 6 months (grades 1, 2);Drug use from 1 to 6 months;Number of chemotherapy delays and dose reductions from 1 to 6 months;Adverse event rate;PFS (Progression-Free Survival);ORR (Objective Remission Rate);DCR (Disease Control Rate);TTP (Time To Progress);Gut microbiota;fecal metabolites;Cytokine; | — |
Countries
China
Contacts
Public ContactQinghua Yao
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed