A study on comparison of addition of Olanzapine 5 mg versus Olanzapine 10 mg as anti-emetic to standard anti-emetic regime for Doxorubicin and Cyclophosphamide in breast cancer

Phase 3

• Conditions: Health Condition 1: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2020/01/023076
• Lead Sponsor: o Funding Available

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

This study will include patients receiving doxorubicin and cyclophosphamide regimen in the adjuvant setting and those who were on olanzapine as one of the antiemetic prophylaxis:

Adults aged 18 years and above;

Chemotherapy-naive breast cancer of any stage;

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (19);

Written informed consent;

Able to understand and describe patient-reported outcomes.

Subjects who were on medications such as antibiotics and motility enhancers such as metoclopramide shall be included after a washout period of 7 days.

Exclusion Criteria

This study will exclude the following subjects:

Scheduled to receive abdominal or pelvic radiotherapy within 8 days of Day 1 of the study;

Acute surgical conditions such as gastrointestinal obstruction, appendicitis, and pancreatitis;

History of hypersensitivity or allergy to any of the study drugs or similar compounds;

Symptomatic brain metastasis, or gastrointestinal tumours;

Liver and renal function derangements;

Left ventricular ejection fraction <50%;

Documented Parkinsonââ?¬•s disease;

Patients on antipsychotic drugs such as chlorpromazine, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone;

Patients on antiepileptic drugs;

Pregnant or breastfeeding women and women of childbearing potential, as well as men wishing to father children;

Habitual smoking;

History of using any of the following drugs within 48 h before enrolment: opioids, aprepitant, 5-HT3-RA, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepines or phenothiazine antipsychotic agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified