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A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer

A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer - A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019122
Enrollment
76
Registered
2015-09-26
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

gynaecological cancer

Interventions

control group (standard antiemetic therapy:0.75 mg palonosetron administered intravenously on day 1 and 6 mg dexamethasone administered intravenously on day 1 and 4 mg dexamethasone administered orall

Sponsors

Juntendo Nerima Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 20 years of age with gynaecological cancer who were scheduled to receive single-day chemotherapy with a carboplatin target area under the concentration curve of 5, and paclitaxel at 175 mg/m2. All patients had an Eastern Cooperative Oncology Group performance status of 0-2, adequate renal function, adequate hepatic function, and adequate marrow function. All patients provided written informed consent for their participation in the study.

Exclusion criteria

Exclusion criteria: receipt of any agent that could affect the study results (such as an antiemetic, steroid, or pimozide) before the start of chemotherapy; symptomatic brain metastasis; gastro-intestinal obstruction or any other condition that could provoke nausea and vomiting; and a known allergy or severe reaction to any of the study drugs.

Design outcomes

Primary

MeasureTime frame
complete response (CR, defined as complete absence of emetic events) in the delayed phase

Countries

Japan

Contacts

Public ContactYayoi Sugimori

Juntendo Nerima Hospital Department of Obstetrics and Gynecology

ysugi-junten@umin.ac.jp03-5923-3111

Outcome results

None listed

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