Olanzapine for control of carboplatin induced nausea and vomiting

Phase 3

• Conditions: Health Condition 1: C34- Malignant neoplasm of bronchus andlungHealth Condition 2: C15-C26- Malignant neoplasms of digestive organsHealth Condition 3: C51-C58- Malignant neoplasms of female genital organsHealth Condition 4: C00-C14- Malignant neoplasms of lip, oral cavity and pharynxHealth Condition 5: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissueHealth Condition 6: C60-C63- Malignant neoplasms of male genital organs

• Registration Number: CTRI/2021/03/032165
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Patients with pathologically confirmed malignancies

2Age =18 years

3Chemo-naïve

4Scheduled to receive first cycle of carboplatin-based chemotherapy with AUC=4

5Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

6Meeting the following standard values of general clinical tests:

aANC >1000

bAspartate aminotransferase =100U/L.

cAlanine aminotransferase =100U/L.

dTotal bilirubin =2.0mg/dL.

7Written informed consent

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of patient with complete response(no vomiting and no use of rescue medications)Timepoint: Overall period(0-120 hours)post chemotherapy <br/ ><br>Acute period(0-24 hours)post chemotherapy <br/ ><br>Delayed period(25-120 hours) <br/ ><br>;Proportion of patient with no nausea(ESAS score-0)Timepoint: Acute period(0-24 hours) <br/ ><br>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) <br/ ><br>Acute period(0-24 hours) <br/ ><br>Delayed period(25-120 hours)