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Comparison of the effectiveness of olanzapine, metoclopramide and domperidone for controlling chemotherapy related nausea and vomiting

Phase 2
Conditions
Health Condition 1: C00-D49- Neoplasms
Registration Number
CTRI/2018/11/016359
Lead Sponsor
Jawaharlal Institute Of Postgraduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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