A pilot study of efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer.
- Conditions
- cervical cancer
- Registration Number
- JPRN-UMIN000003979
- Lead Sponsor
- ara Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Not provided
1. patients with received pimozide. 2. patients with history of chemotherapy with cisplatin. 3. patients with vomiting within 24 hours before first administrating of cisplatin. 4. patients who have had any other cancer. 5. patients who are pregnant or breast feeding. 6. patients with severe complications (heart disease, uncontrolled diabetes,bleeding tendency). 7. patients with active infection disease whom steroid is inappropriate for. 8. patients who have a history of hypersensitivity to drugs. 9. patients who were administered drugs in the following, 5-HT3 blocker, phenothiazine, butyrophenone, benzamide, dopamine receptor antagonist. 10. patients who are considered to be inappropriate for this study judged by the treating physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of nausea, vomiting, fatigue and headache as graded by CTCAE v.4.0 with or without aprepitant.
- Secondary Outcome Measures
Name Time Method 1. the evaluation of QOL using FLIE. 2. the proportion of patients who completed more than 5 courses. 3. comparison of 6B-OHF in urine. 4. adverse events.