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Randomized double blind study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen against the gynecologic cancers

Randomized double blind study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen against the gynecologic cancers - Randomized study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005215
Enrollment
320
Registered
2011-04-01
Start date
2011-04-01
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

Gynecologic cancer

Interventions

Oral medication for 3 days (day 1: 125mg, day2-3 80mg) Oral medication for 3 days(placebo)

Sponsors

Kyushu University Obstetrics gynecology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Patient of gynecologic cancer who received TC regimen as first line chemotherapy 2. Age: 20-80 years old 3. PS: 0-2 4. Patients who sign informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with severe liver or renal dysfunction 2.Patients with nausea or vomiting before chemotherapy within 24 hours 3.Patients who received antiemetic drug before chemotherapy within 48 hours 4.Patients who continuously received anti-allergic drug or steroid 5.Patients with a current diagnosis that induced nausea or vomiting 6.Patients who received prior abdominal or pelvic radiotherapy 7.Patients with DM required continuous insulin therapy 8.Patients with pregnancy 9.Patients who judged that the doctor is inadequate

Design outcomes

Primary

MeasureTime frame
Rate of hypersensitive reaction

Secondary

MeasureTime frame
Rate of the patient without vomiting Rate of the patient without significant nausea

Countries

Japan

Contacts

Public ContactHideaki Yahata

Kyushu University Obstetrics gynecology

092-642-5395

Outcome results

None listed

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