Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

Date de début de l'étude : 1 février 2012

Inclusion Criteria: Male or female aged over 20 yrs Histologically and/or cytologically proven cancer patients Eastern Cooperative Oncology Group performance status 0, 1, 2 A cycle of moderately emetogenic chemotherapy(NCCN Guidelines) Life expectancy of ≥ 3 months Normal liver function and renal function(total bilirubin ≤ 1.5 ULN, AST/ALT ≤ 2.5 ULN, in case of liver metastases AST/ALT ≤ 5 ULN, serum creatinine ≤ 1.5 ULN) patients Patients who signed the informed consent form Exclusion Criteria: A. Previous History Hypersensitivity to adhesive plasters Contraindications to 5-HT3 receptor antagonists Any other relevant medical history (at the discretion of the investigator) B. Concomitant Medical Condition Current alcohol, drug or medication abuse Currently pregnant or breast feeding women, including planning pregnancy Clinically relevant abnormal laboratory values (at the discretion of the investigator) Clinically relevant heart, hepatic, renal, infectious, neurological or psychiatric disorders, or any other major systemic illness (at the discretion of the investigator) Any cause for nausea and vomiting other than CINV Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to the chemotherapy administration Clinically relevant abnormal ECG parameters (at the discretion of the investigator) C. Concomitant Therapy/Medication Concomitant radiotherapy of total body, brain or upper abdomen within one week prior to the study entry or planned during the study Intake of medication to control the symptoms of a brain tumor, brain metastasis or seizure disorder or neuropathy (unless peripheral neuropathy at the discretion of the investigator) Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a stable dose for the duration of the study) Receipt of a narcotic analgesics (acceptable at the discretion of the investigator) Receipt of any other clinical trial drug < 30 days before the study or during the study Scheduled to receive a neurokinin NK1 receptor antagonist, dopamine receptor antagonist or another 5-HT3 receptor antagonist at 72 h prior to the administration of the chemotherapy or scheduled to do those medication during chemotherapy duration Drugs known to increase the QTc interval (unless a stable dose for the duration of the study at the discretion of the investigator) D. Other Patients unlikely to comply with the study protocol (at the discretion of the investigator), e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study The patch adhesion level was not more than 50% on the day of chemotherapy or the patch was not attached within two days before the chemotherapy