Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy
Phase 4
- Conditions
- non-Hodgkin lymphoma
- Registration Number
- JPRN-UMIN000004495
- Lead Sponsor
- Division of Hematology, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
The use of drugs which affect metabolism of aprepitant and prednisolone, the use of antiemetics or drugs with antiemetic effect which is not prescribed within 48 hours before (R-)CHOP initiation, irradiation to the abdomen or pelvis within 6 days before (R-)CHOP initiation, the onset of vomitting or dry vomiting within 24 hours before (R-)CHOP initiation, symptomatic brain metastasis, beeing pregnant or lactating, the possibility of pregnancy, using oral contraceptive, previous use of aprepitant, diabetes mellitus with drug treatment, HbA1c >= 6.5 %, fasting blood glucose >= 126 mg/dl, psychiatric disorder, a patients who is considered as ineligible by the attending doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of prednisolone (and its metabolites). They are measured from day 3 to day 4 in the first (without aprepitant) and the second (with aprepitant) courses of (R-) CHOP therapy in every patient.
- Secondary Outcome Measures
Name Time Method