A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients.

A single-blind randomized controlled trial comparing Aprepitant plus (Granisetron)1st 5-HT3 receptor antagonist and Palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies including CBDCA in the gynecology cancer patients. - A single-blind randomized controlled trial for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in the gynecology cancer patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008552

Enrollment

300

Registered

2012-08-01

Start date

2012-08-01

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

Patients with gynecologic cancer receiving chemotherapy including carboplatin (that is, TC therapy: carboplatin + paclitaxel)

Interventions

Antiemetic therapy with palonosetron and dexamethasone Triple antiemetic therapy with a 5-HT3 receptor antagonist, dexamethasone and a NK1 receptor antagonist (fosaprepitant)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients with gynecologic cancer undergoing chemotherapy including carboplatin (>AUC 5) for the first time. 2. Patients in whom the regimen used in the first chemotherapy course is also planned for the second and later courses. 3. Patients who gave written consent to participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients complicated with serious hepatic disorders or renal disorders. 2. Patients with nausea and vomiting within 24 hours before initiation of cancer chemotherapy. 3. Patients who used an antiemetic agent within 48 hours before initiation of cancer treatment. 4. Patients with nausea and vomiting due to causes (brain tumor, digestive passage disorders, active peptic ulcer, brain metastasis, use of opioids, etc.) other than cancer chemotherapy. 5. Patients with an associated disease, including uncontrolled diabetes, that prevents administration of dexamethasone for three days. 6. Patients under medication with pimozide. 7. Patients for whom abdominal radiotherapy is planned. 8. Patients with a history of vomiting in past chemotherapy. 9. Patients judged to be inappropriate for the study by the physician in charge.

Design outcomes

Primary

Measure	Time frame
The primary endpoint was the percentage of patients with a complete response (no vomiting and no salvage treatment) throughout the first course of chemotherapy.	—

Countries

Japan

Contacts

Public ContactTatsuru Ohara

St. Mariannna University, School of Medicine Department of Obstetrics and Gynecology

hffbd516@yahoo.co.jp044-977-8111

Outcome results

None listed

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