Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.

Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy. - PROEMEND PK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013782

Enrollment

Registered

2014-04-22

Start date

2014-04-01

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

Inoperable advanced/recurrence Gastric Cancer or Esophageal Cancer or Colorectal Cancer

Interventions

Group A: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. * 2nd course: Palonosetron 0.75mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who receive the first cycle of chemotherapy with high emetic risk chemotherapy. (2) Performance Status (ECOG)=0-2

Exclusion criteria

Exclusion criteria: (1) Patient who is taking Pimozide. (2) Patient who has severe liver failure or renal failure. (3) Patient who had been treated with one moderate risk emetogenic antitumour drug according to the 2014 National Comprehensive Cancer Network Clinical Practice Guidelines. (4) Patient who has vomited or provoked nausea in the 24 hours prior to start of chemotherapy. (5) Patient who is considered inappropriate as a target patient by a physician-in-charge.

Design outcomes

Primary

Measure	Time frame
* Blood concentration of dexamethasone	—

Secondary

Measure	Time frame
* Frequency of vomiting * Severity of nausea * Grading of appetite * Used amount of per-request medication	—

Countries

Japan

Contacts

Public ContactMasahiro Goto

Osaka Medical College Hospital Cancer Chemotherapy Center

in2030@osaka-med.ac.jp072-683-1221

Outcome results

None listed

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