cervical cancer
Conditions
Interventions
Goreisan 7.5g per day
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed uterine cervical cancer of clinical stage IB2-IVa in whom cisplatin-based CCRT was planned as both primary and adjuvant treatments 2) Age >20 years, <75 years; 3) Performance status =<2; 4) With written informed consent obtained before participation; 5) No prior radiother
Exclusion criteria
Exclusion criteria: 1) Inflammatory bowel disease such as Crohn disease and ulcerative colitis 2) Severe hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase >=100 U/L) 3) Severe renal dysfunction (serum creatinine >=1.5 mg/dL or blood urea nitrogen >=25 mg/dL) 4) Mental illness that may require the administration of antipsychotics, and dementia 5) Current use of other oriental medicine 6) A history of the hypersensitivity that is serious for the study medicine, or drug allergy 7) Any case that the chief physician judges to be inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence rate of >grade 2 diarrhea as measured by the Common Terminology Criteria for Adverse Events v4.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Protection period of diarrhea (total treatment duration - total days of >grade 2 diarrhea / total treatment duration); 2) Time to the first occurrence of >grade 2 diarrhea from the first day of treatment; 3) Adverse effects; 4) Frequency of diarrhea and transition of the grade of diarrhea. | — |
Countries
Japan
Contacts
Public ContactSinsuke Hanawa
Chiba University Hospital Gynecology
Outcome results
None listed