A Clinical Trial Study to evaluate the efficacy and safety of Palonosetron for the prevention of acute-onset and delayed-onset chemotherapy induced nausea and vomitting following the administration of either moderately or highly emetogenic chemotherapy regimens
- Conditions
- Health Condition 1: null- Chemotherapy Induced Nausea and Vomitting
- Registration Number
- CTRI/2010/091/001078
- Lead Sponsor
- Themis Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Patients of either sex in the age group between 18 to 70 years.
2. Patients with histologically or cytologically confirmed malignant disease.
3. Patients with malignancy at sites other than head and neck or upper gastrointestinal regions.
4. Patients scheduled to receive a single day of moderate to severe emetogenic chemotherapy for the given malignancy with any of the following anti-cancer drugs in the given doses (for ≤ 4 courses): (1) Cisplatin / Carboplatin > 60 mg/m2. (2) Cycloposphamide > 1100 mg/m2. (3) Doxorubicin > 25 mg/m2. (4) Methotrexate > 250 mg/m2. (5) Dacarbazine, Irinotecan, Epirubicin.
5. The Chemotherapy administration must be for ≤ 4 hours and the duration of each course ≤ 28 days.
6. The Chemotherapy must cause nausea and vomitting in 30-100 % of patients if untreated according to Hesketh algorithm.
7. Patients must not be suffering from greater than mild nausea or any vomitting within 24 hours before beginning study treatment.
8. Patients with Body performance status (PS) between 0 to 2 and normal ECG recording and normal Liver Function Tests.
9. Patient ready to give informed consent.
1. Patients admitted in intensive care unit to the hospital for indication other than chemotherapy treatment.
2. Patients with associated multi-organ involvment / septicemia.
3. Patients having concomitant chronic infections e.g. tuberculosis.
4. Patients presenting with prolongation of cardiac conduction intervals (QTc interval ≤500 ms) cardiac abnormality predisposing the patient to arrhythmia and electrolyte disturbances.
5. Patients with severe cardiac, hepatic and renal diseases. (SGOT upper limit of normal (ULN). SGPT and S. Bilirubin ULN, S.creatinine ULN).
6. Immuno-compromised and malnourished patients.
7. Pregnant and lactating females.
8. Patients with psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation.
9. Patients with recent history (i.e. ≤ 1 year) of alcohol or drug abuse.
10. Known hypersensitivity to Palonosetron and other 5-HT3 receptor antagonists.
11. Patients must not be scheduled to receive radiotherapy 7 days prior to, during and 5 days after completion of study treatment.
12. Prior chemotherapy must be complete atleast 10 days before enrollment.
13. Patients should not be receiving concurrent prohibited medications (e.g. CYP3A4 inhibitors or other antiemetic medications) or within the last 10 days prior to enrollment.
14. Patients should not be receiving any anti-nausea medications within the last 7 days prior to enrollment.
15. Patients should not be treated concomitantly / within the last 30 days prior to enrollment with any investigational products.
16. Simultaneous participation in another clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with Overall response during the acute phase, delayed-onset phase and during chemotherapy course. Overall response is defined as no occurrence of nausea / vomitting during acute phase (0-24 hours) and during delayed-onset phase (24 - 120 hours)Timepoint: Overall response is defined as no occurrence of nausea / vomitting during acute phase (0-24 hours) and during delayed-onset phase (24 - 120 hours)
- Secondary Outcome Measures
Name Time Method 1.Proportion of patients with complete response(CR)during acute & delayed onset phase after administration of chemo course.Complete response is defined as no occurrence of nausea/vomitting during the acute&delayed onset phase. <br/ ><br>2.Total use of rescue medication. <br/ ><br>3.Patients global satisfaction with antiemetic therapy during acute phase and delayed phase during chemotherapy course.Timepoint: 1. During acute onset phase (0-24 hours) after administration of chemotherapy course. <br/ ><br>2. During delayed onsent phase (24-120 hours) after administration of chemotherapy course. <br/ ><br>3. Number of emetic episodes/ severity(as recorded on VAS)during the acute and delayed onset phase, evaluated at 0, 8 hourly on day 1 and daily from day 2 to day 5. <br/ ><br>