Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy

Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy - Investigation of the efficacy of aprepitant and its drug interaction with prednisolone in (R-)CHOP therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004495

Enrollment

Registered

2010-11-03

Start date

2010-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-Hodgkin lymphoma

Interventions

Antiemesis therapy with granisetron is performed on day 1 in the 1st course of (R-) CHOP therapy. In the 2nd course, 125 mg of aprepitant per os in a single administration, and 60 mg per os in a singl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A patient with non-Hodgkin lymphoma who is to be treated with (R-)CHOP therapy for the first time. Performance status (ECOG) grade 0 - 2, with estimated life expectancy of 3 months or more, and with sufficient blood count, liver and renal function.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYasushi Okoshi

University of Tsukuba Division of Hematology

yokoshi@md.tsukuba.ac.jp029-853-3127

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026