Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Arm B (OPF regimen): Intervention arm: Day 1
Olanzapine 5 mg PO once7
Palonosetron 0.25 mg IV once
Dexamethasone 12 mg IV once
Intervention2: Arm B (OPF regimen): Intervention arm: Dur
Sponsors
Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 80 years and diagnosed with cancer. 2. Chemotherapy naïve. 3. Receiving single day Highly Emetogenic Chemotherapy. 4. Absence of nausea or vomiting 24 hours before enrollment. 5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 6. Adequate organ function as confirmed by laboratory investigations within 2 weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within 5 times the upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN]. 7. Hb more than 7 gms%, WBC more than 4000/cumm and platelets more than 100,000/cumm. 8. No concurrent use of quinolone antibiotic therapy. 9. No severe alcohol use disorder as defined by Diagnostic Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 10. Women enrolled in the trial need to have a negative pregnancy test within seven days of enrollment and continue to practice contraception during the study period. 11. Written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1. Pediatric patients (age less than 18 years) 2. Patients receiving steroids as part of the chemotherapy regimen or needed as pre-medication for the prevention of allergic reactions. For eg: paclitaxel and carboplatin. 3. Patients receiving multi-day chemotherapy in a chemotherapy block. 4. Patients with brain metastasis. 5. No abdominal radiotherapy. 6. Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension, and active peptic ulcer disease. 7. History of allergy to any of the drugs used for anti-emetic prophylaxis. 8. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during the protocol therapy. 9. Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months. 10. History of neurological disorders including seizures and stroke within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the complete response (CR) rates for vomiting with non-dexamethasone based OPF regimen with the dexamethasone based OPD regimen in patients receiving HEC.Timepoint: Primary outcome will be assessed on day 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the two study regimens for the number of patients with a CR for nausea 2. To evaluate the adverse effects of the two regimens 3. To compare the QOL between the two regimens. Timepoint: â?¢ Secondary endpoints: CR to vomiting during the acute phase (0 to 24 hours) and the delayed phase (24 to 120 hours); severity of nausea; comparison of QOL and toxicities between the two regimens. | — |
Countries
India
Contacts
Public ContactVenkatraman Radhakrishnan
Cancer Institute
Outcome results
None listed