The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy - The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009311

Enrollment

Registered

2012-11-15

Start date

2012-11-15

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

Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA)

Interventions

We administer three antiemetic drugs(5-HT3 antagonist, dexamethasone and fosaprepitant) from the next course for the patients who experienced nausea and vomiting by two antiemetic drugs(5-HT3 antagon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA) 2)We use palonosetron as 5-HT3 antagonist 3)Clinical stage: do not ask 4)Molecular target drug: do not ask 5)Documented informed consent

Exclusion criteria

Exclusion criteria: 1)Serious complications (e.g. severe liver disfunction or renal disfunction) 2)Patients with factors besides chemotherapy(e.g. brain tumor, passage disorder of digestive tract, active digestive ulcer, brain metastases) 3)Poorly controlled diabetes 4)Pregnant or lactating women or women of childbearing potential 5)Patients during pimozide administration 6)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
>Patients rate who required triple-drug therapy because of a digestive symptom(nausea and vomiting) >Improvement rate of the digestive symptom(nausea and vomiting) by the triple-drug therapy	—

Secondary

Measure	Time frame
>Patients rate without vomiting >Patients rate of Complete Response (without vomiting and rescue) >Patients rate of Complete Protection (without vomiting, rescue, moderate or severe nausea) >Patients rate without nausea >Patients rate without moderate or severe nausea >Frequency distribution of nausea and vomiting >Successful treatment period >Intake situation	—

Countries

Japan

Contacts

Public ContactMasanobu Takahashi

Tohoku University Hospital Department of Clinical Oncology

mtakahashi@idac.tohoku.ac.jp022-717-8543

Outcome results

None listed

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