Patient with breast cancer. Malignant neoplasm of unspecified site of unspecified female breast
Conditions
Interventions
Intervention 1: Intervention group 1: Eligible patients will receive: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on day 1, 80 mg OD on days 2-3), Granisetron (1 mg IV only on da
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Nausea in the Group receiving Mirtazapine. Timepoint: During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 ?days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Severity of Nausea in the Group receiving Olanzapine. Timepoint: During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 ?days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Comparison of the Severity of Nausea in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 ?days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Severity of Vomiting in the Group receiving Mirtazapine. Timepoint: During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 ?days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Severity of Vomiting in the Group receiving Olanzapine. Timepoint: During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 ?days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;?Comparison of the Severity of Vomiting in Two Groups receiving Mirtazapine and Olanzapine. Ti | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of The Quality of Life in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: 120 Hours after Initiation of Chemotherapy. Method of measurement: 18-item Functional Living Index-Emesis (FLIE) Questionnaire.;Severity of adverse Events in the Group receiving Mirtazapine. Timepoint: ?During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 ?Days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Severity of adverse Events in The Group receiving Olanzapine. Timepoint: During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 ?Days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Comparison of the Severity of adverse Events in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 ?Days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Comparison of the Severity of Somnolence in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 ?Days). Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Comparison of the Severity of Anorexia in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaria Tavakoli-Ardakani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed