A study on antiemetic drugs in breast cancer chemotherapy

A prospective observational study on the optimization of four-drug antiemetic therapy including fosnetupitant and olanzapine for perioperative epirubicin-cyclophosphamide therapy in breast cancer - A prospective observational study on the optimization of four-drug antiemetic therapy including fosnetupitant and olanzapine for perioperative epirubicin-cyclophosphamide therapy in breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054250

Enrollment

100

Registered

2024-05-01

Start date

2024-05-02

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

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Early-stage or locally advanced breast cancer. 2. No prior chemotherapy and scheduled to receive epirubicin and cyclophosphamide (EC) or dose-dense EC therapy. 3. ECOG Performance Status 0 or 1.

Exclusion criteria

Exclusion criteria: 1. Concurrent use of antiemetic agent. 2. Start of opioid analgesic for 14 days before registration. 3. Subjects on anticonvulsant therapy. 4. Gastrointestinal obstruction (e.g. gastropyloric stenosis, intestinal obstruction). 5. Diagnosis of diabetes mellitus(e.g., on insulin or an oral hypoglycemic agent).

Design outcomes

Primary

Measure	Time frame
No nausea during the overall assessment period (0 to 120 hours) on the first course	—

Secondary

Measure	Time frame
1. Complete response 2. Complete control 3. Total control 4. Time to treatment failure 5. Daytime somnolence 6. Change in dosage of olanzapine 7. Satisfaction with antiemetic therapy	—

Countries

Japan

Contacts

Public ContactAyako Higuchi

National Hospital Organization Kyushu Cancer Center Department of Pharmacy

higuchi.ayako.jn@mail.hosp.go.jp092-541-3231

Outcome results