Health Condition 1: R112- Nausea with vomiting, unspecified
Conditions
Interventions
Intervention1: NEPA (Netupitant 300mg and Palonosetron 0.50mg): Patients in arm A will receive NEPA (Netupitant 300 mg plus Palonosetron 0.50 mg)once 60 mins prior to chemotherapy with 12mg IV dexamet
Sponsors
Prince Aly Khan Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chemotherapy-naive patients. 2. Adult male and female subjects aged >=18 years 3. Scheduled to receive HEC regimen. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0â??1 5. Adequate general condition (white blood cell count 3Ã?109 cells/ L), hepatic function (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] 6. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Seizure disorder needing anticonvulsants, unless clinically stable; 2. Any Prior vomiting, retching, or grade 2 or higher nausea according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE); 3. Asymptomatic metastases to the brain 4. Known hypersensitivity to palonosetron, Netupitant or dexamethasone excipients 5.Pregnant/breast-feeding women 6. Those receiving any drug with antiemetic effects 7. Those who were unable to cooperate or judged by an investigator to be unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) from chemotherapy administration. (CR is defined as no emetic episode and no use of rescue medication)Timepoint: 0-120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CR during acute (0-24 hours) and delayed (24-120 hours) phases, Complete control (CC) during the overall phase and safety of these antiemetic therapies (CC is defined as CR and no significant nausea ( VAS 2.5mm)) 2. Time to failure (i.e., time to first emetic episode or time to rescue) may be interesting secondary end-points 3. Evaluation as per MASCC (Mutinational Association of Supportive care in cancer) Chemotherapy Induce nausea Vomiting (CINV) Risk Score Timepoint: 1. 0-24 hours, 24-120 hours,VAS 2.5mm | — |
Countries
India
Contacts
Public ContactDr Adwaita Gore
Prince Aly Khan Hospital
Outcome results
None listed