Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Tablet domperidone: 10 mg per oral three times a day for 3 days,for use in chemotherapy induced nausea and vomiting
Intervention2: Tablet Metoclopramide: 10 mg per oral three times a da
Sponsors
Jawaharlal Institute Of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed malignant disease 2.Chemotherapy naïve patients 3.Scheduled to receive intravenous either single or multiday highly emetogenetic chemotherapy regimens or moderately emetogenic chemotherapy regimens
Exclusion criteria
Exclusion criteria: 1.Patients with nausea in 24 h prior to beginning of chemotherapy 2.serum creatinine of >2.0 mg/dl, serum bilirubin of >2.0 mg/dl, SGOT or SGPT values of >3 times the upper limits of normal 3.Pregnant patients 4.Patients on chemotherapy for leukemia. 5.Esophageal and stomach malignancies are excluded from the study. 6.Patients on continuous, intermittent or concomitant oral chemotherapy 7.Patients on continuous, intermittent or concomitant oral chemotherapy or on opioid (morphine) treatment for pain control. 8.Patients with known hypersensitivity to olanzapine, metoclopramide or domperidone, 9.Patients with cardiac arrhythmia, history of congestive heart failure, or acute myocardial infarction within the previous 6 months. 10.Patients with known history of CNS disease (e.g., brain metastases, seizure disorder), or treatment with any antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for 30 days prior to or during protocol therapy. 11.Patients with concurrent abdominal radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the efficacy of metoclopramide, olanzapine, domperidone in symptom abolishment of chemotherapy induced breakthrough nausea and vomitingTimepoint: over 1 year of DM course | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare QOL before and after onset of breakthrough CINV and use of study medicationsTimepoint: over 1 year of DM course;To assess and compare the side effect profile of metoclopramide, olanzapine, domperidone in the treatment of breakthrough vomitingTimepoint: over 1 year of DM course;To assess the use of second line rescue for treatment of breakthrough emesisTimepoint: over 1 year of DM course | — |
Countries
India
Contacts
Public ContactBhanu Prakash Bandlamudi
Jawaharlal institute of medical education and research
Outcome results
None listed