Health Condition 1: C34- Malignant neoplasm of bronchus andlung Health Condition 2: C15-C26- Malignant neoplasms of digestive organs Health Condition 3: C51-C58- Malignant neoplasms of female genital organs Health Condition 4: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 5: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue Health Condition 6: C60-C63- Malignant neoplasms of male genital organs
Conditions
Interventions
Intervention1: Olanzapine: 5 mg on day 1(30 min prior to chemotherapy), followed by 5 mg on day 2 to day 4(in morning hours)
Intervention2: Olanzapine,Ondansetron, Dexamethasone: a. Olanzapine: 5 mg o
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients with pathologically confirmed malignancies 2 Age =18 years 3 Chemo-naïve 4 Scheduled to receive first cycle of carboplatin-based chemotherapy with AUC=4 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 6 Meeting the following standard values of general clinical tests: a ANC >1000 b Aspartate aminotransferase =100U/L. c Alanine aminotransferase =100U/L. d Total bilirubin =2.0mg/dL. 7 Written informed consent
Exclusion criteria
Exclusion criteria: • Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy • Any history of CNS disease including brain metastasis, seizure disorder or psychosis • Active infection or uncontrolled medical condition other than malignancy • Need for medication that strongly induces CYP3A4 activity (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) • Patients on systemic steroids other than for use as an antiemetic agent • Prior aprepitant/fosaprepitant or olanzapine use. • Planned to receive quinolone antibiotics while receiving olanzapine. • Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducer or inhibitors. • Received radiotherapy to abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation • Hypersensitivity to olanzapine or fosaprepitant • Cardiac arrhythmia, uncontrolled congestive heart failure or acute MI within the previous 6 months. • Uncontrolled Diabetes mellitus • Pregnant or breast-feeding females or those not willing for contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with no nausea(ESAS score-0)Timepoint: Proportion of patients with no nausea(ESAS score-0) during overall period (0-120 )hours after chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient with complete response(no vomiting and no use of rescue medications)Timepoint: Overall period(0-120 hours)post chemotherapy Acute period(0-24 hours)post chemotherapy Delayed period(25-120 hours) ;Proportion of patient with no nausea(ESAS score-0)Timepoint: Acute period(0-24 hours) Delayed period(25-120 hours);Total control(no nausea.no vomiting and no use of rescue medication)as measured on ESASTimepoint: Overall period(0-120 hours) Acute period(0-24 hours) Delayed period(25-120 hours) | — |
Countries
India
Contacts
Public ContactAKASH JHA
AIIMS
Outcome results
None listed