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Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients

Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients - Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced nausea and vomiting

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000304
Enrollment
180
Registered
2006-01-11
Start date
2006-01-01
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

breast cancer , ovarian cancer , cervical cancer , endometrial cancer , etc

Interventions

Granisetron 1mg/body (drip on intravenous,day1) Granisetron 3mg/body (drip on intravenous,day1)

Sponsors

Pharmacy Division of National Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)20 years-old over (2)PS (Eastern Cooperative Oncology Group performance status scale) 0-2 (3)patients to use the neoplastic agents belong to the acute emetic High risk category <refer to the ASCO clinical practice guideline,Recommendations for the use of Antiemetics> (4)Each of the following values are examined within 3weeks before registration for this study 1)ANC>=1,000/mm2 2)GPT(ALT) <100IU/L 3)CRE<=1.5 (CBDCA:CRE<=2.5) (5)Written informed consent

Exclusion criteria

Exclusion criteria: (1)patients with known hypersensitivity to 5-HT3 receptor antagonist (2)patients to use the neoplastic agents belong to the acute emetic category intermediate and High risk or to do the radiation therapy between Day2 and 7 (3)serious complications excepting malignancy (e.g. bowel obdormition, fibroid lung, cerebrovascular accident, active gastric and duodenum) (4)can't exactly record episodes in diaries, Shoujyou-nisshi

Design outcomes

Primary

MeasureTime frame
Complete Response

Secondary

MeasureTime frame
Complete control

Countries

Japan

Contacts

Public ContactMasahito Yonemura

Granisetorn coordinating office Pharmacy Division of National Cancer Center Hospital

myonemur@ncc.go.jp03-3542-2511

Outcome results

None listed

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