Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Not Applicable
- Conditions
- cervical cancer
- Registration Number
- JPRN-UMIN000016681
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence rate of >grade 2 diarrhea as measured by the Common Terminology Criteria for Adverse Events v4.0.
- Secondary Outcome Measures
Name Time Method 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.