Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Chemotherapy

Phase 3

Recruiting

• Conditions: Patient with breast cancer.; Malignant neoplasm of unspecified site of unspecified female breast; C50.919

• Registration Number: IRCT20100127003210N19
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

Patients with Newly Diagnosed Breast Cancer
Receiving Anthracycline-Cyclophosphamide Chemotherapy Regimen in the adjuvant Setting for at least Two consecutive Cycles
Patients aged 18 to 65
Written Informed Consent
The Patient is able to read and understand the Questionnaires used in the Study

Exclusion Criteria

A History of Allergy to Mirtazapine or Olanzapine
Patient with History of Dementia, peptic Ulcer, myocardial Infarction, Seizure, Arrhythmia, Glaucoma, and bipolar Disorder
Concomitant use of any Drug with Class X and D Interaction with the Drugs studied
Increased basal Creatinine (SrCr = 1.5) or AST or ALT = 3ULN
Brain Metastasis or Metastases with gastrointestinal Obstruction
Having Nausea and Vomiting within 24 hours prior to Chemotherapy
Patients with Disabilities taking oral Medications
On chronic antiemetic Therapy (e.g.Metoclopramide); on long Term use of systemic Steroids prior to Chemotherapy
Uncontrolled Diabetes
The Patient has a History of any Illness that, in the Opinion of the Investigator, might confound the Results of the Study or pros unwarranted Risk

Study & Design

• Study Type: interventional
• Study Design: Not specified