Health Condition 1: R110- Nausea
Conditions
Interventions
Intervention1: Standard therapy with Thalidomide: Thalidomide 50mg per day is given from day 1 to day 5 of post second chemotherapy cycle along with the standard anti-emetic prophylaxis (Olanzapine, A
Sponsors
Jawaharlal Institute of Postgraduate Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Patients receiving first-line therapy with one of the below HEC regimens: ? Anthracycline/Cyclophosphamide combination ? Regimens with Cisplatin > 50 mg /m2 ? ABVD regimen 3. Patients must provide written informed consent (including consent for telephonic conversation/questionnaire both in the current and next cycle of chemotherapy). 4. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, and 2 at the time of enrolment in the study 5. Adequate blood counts and organ functions: ? ANC: > 1500/cumm ? Total Bilirubin= 1.5 x ULN ? AST (SGOT) = 3 x ULN ? ALT (SGPT) = 3 x ULN ? Serum creatinine = 2 mg/dL or measured creatinine clearance = 40 mL/min according to Cockcroft-Gault formula 6. Nausea/Vomiting of any grade in the acute/delayed period of first chemotherapy cycle. 7. Receiving the same chemotherapy without dose modifications in the second cycle. 8. Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) within past 7 days of enrollment and willing to adapt childbirth control throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Nausea/vomiting in the past 24 hours (prior to initial enrolment and prior to 2nd HEC cycle). 2. The following malignancies will be excluded as they will cause GI symptoms: GI/ Hepato pancreaticobiliary malignancies, ovarian cancers 3. Severe neurocognitive impairment. 4. Known history of central nervous system organic disorder (e.g., Brain metastasis/malignancy, raised ICT) 5. Known psychiatric disorder 6. Pre-existing > grade 2 peripheral neuropathy 7. Human Immunodeficiency Virus (HIV) infection/and or on anti-retroviral therapy and/ or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study). 8. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study). 9. Concurrent radiotherapy 10. Regular alcohol intake (3 or more drinks equivalent of 45 ml of liquor per week) 11. No known hypersensitivity to the study agents 12. No known cardiac arrhythmia, uncontrolled CHF, or acute MI within the last 6 months 13. No history of uncontrolled DM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare between the thalidomide and placebo for the number of patients with no nausea in the overall period (0 - 120 hours of post-chemotherapy) in patients receiving HEC and had nausea/vomiting after standard anti-emetic prophylaxis in previous HEC cycle and are receiving the same chemotherapy in the current cycleTimepoint: From the 0 to 120 hours of 2nd chemotherapy cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the two study arms, the number of patients achieving: 1. Complete response (CR) (no emetic episodes and no use of rescue medications) in the acute, delayed, and overall period. 2. “No nausea ? in the acute period (0-24 hours) 3. “No nausea ? in the delayed period (24-120 hours) 4. Adverse events that are possibly due to Thalidomide 5. Quality of life on day 6 of chemotherapyTimepoint: 5 days | — |
Countries
India
Contacts
Public ContactDr Nishil Gowda
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed