Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Olanzapine Arm: Tab or Injection Ondansteron 8mg on Day 1
Tab. Olanzapine 5mg once, day 1-3
Control Intervention1: Comparator: Not applicable
Sponsors
NCI
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of malignancy No prior chemotherapy and radiation therapy (RT) Age of >= 18 â?? up to 65 years ECOG Performance status (0-2) Complete hemogram (ANC >=1000/m3, TLC >=3000/m3, Platelets >= 1,00,000/m3), Creatinine ( First cycle of moderately emetogenic chemotherapy defined as Oxaliplatin at dose >=80mg/m2 with or without other agents Willing to give written informed consent for the study participation
Exclusion criteria
Exclusion criteria: Patient receiving concurrent psychiatric drugs (clozapine, risperidone, quetiapine, phenothiazine etc), CNS depressants (azelastine, bromopride, bromperidol, buprenorphine), anti-Parkinson drugs (dopamine agonist), benzodiazepines, cabergoline, anti-cholinergic (glycopyrrolate, ipratropium, levosulpiride, potassium chloride, potassium citrate etc), metoclopramide, pimozide, quinolone, amifostine Hypersensitivity to any of the drugs used in the study {Olanzapine, 5-HT3 antagonist â?? Ondansetron} On systemic steroids History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis Symptomatic Brain metastasis / Carcinomatous Meningitis History of nausea and vomiting in 24 hours prior to first dose of chemotherapy Use of anti-emetic drugs (5-HT3 Antagonist) in last 24 hours Started on opioids in last 48 hours Female who is pregnant, or breast-feeding his children Patients with dementia related psychosis or psychiatric disorder No concurrent abdominal radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapyTimepoint: To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the rate of complete response ((no emesis, no use of rescue medications) during the acute period (0-24 hours), delayed period (24 â?? 120 hours) To determine the rate of nausea control assessed by â??Edmontonsymptomassessment scaleâ?? (ESAS) during the acute period (0-24 hours), delayed period (24 â?? 120 hours) and overall period (0-120 hours) To determine the rate of complete control during the overall period (0-120 hours) To determine the rate of total control during the overall period (0-120 hours) Toxicity pattern and incidence Time to treatment failure Prognostic factors associated with CINV controlTimepoint: 5-7 days | — |
Countries
India
Contacts
Public ContactAkash Kumar
NCI
Outcome results
None listed