Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)

Inclusion criteria

• Male or female aged over 20 yrs
• Eastern Cooperative Oncology Group performance status 0, 1, 2
• Life expectancy of ≥ 3 months
• Assigned to receive a cycle of high emetic (HE) chemotherapy regimen including the daily administration of a cytotoxic regimen with the emetogenic potential of level 5 (Hesketh Classification)
• 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 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 of study entry or planned during the study
• Intake of medication to control the symptoms of a brain tumour, 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 investigational drug < 30 days before the study start 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 after patch removal
• 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