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A pilot study of efficacy and safety of aprepitant with chemoradiotherapy involving weekly cisplatin in patients with cervical cancer.

Not Applicable
Recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
The proportion of nausea, vomiting, fatigue and headache as graded by CTCAE v.4.0 with or without aprepitant.
Secondary Outcome Measures
NameTimeMethod
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.
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