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:

1. Male or female aged over 20 yrs
2. Eastern Cooperative Oncology Group performance status 0, 1, 2
3. Life expectancy of ≥ 3 months
4. 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)
5. Patients who signed the informed consent form

Exclusion Criteria:

A. Previous History

1. Hypersensitivity to adhesive plasters
2. Contraindications to 5-HT3 receptor antagonists
3. Any other relevant medical history (at the discretion of the investigator)

B. Concomitant Medical Condition

1. Current alcohol, drug or medication abuse
2. Currently pregnant or breast feeding women, including planning pregnancy
3. Clinically relevant abnormal laboratory values (at the discretion of the investigator)
4. Clinically relevant hepatic, renal, infectious, neurological or psychiatric disorders, or any other major systemic illness (at the discretion of the investigator)
5. Any cause for nausea and vomiting other than CINV
6. Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to the chemotherapy administration
7. Clinically relevant abnormal ECG parameters at the discretion of the investigator

C. Concomitant Therapy/Medication

1. Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
2. 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)
3. Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a stable dose for the duration of the study)
4. Receipt of a narcotic analgesics (acceptable at the discretion of the investigator)
5. Receipt of any other investigational drug < 30 days before the study start or during the study
6. 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
7. 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

1. 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
2. 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