Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C40-C41- Malignant neoplasms of bone and articular cartilage Health Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 4: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs Health Condition 5: C64-C68- Malignant neoplasms of urinary tract
Conditions
Interventions
Intervention1: Mirtazapine: Mirtazapine will be administered along with the standard triple drug regimen for prophylaxis against chemotherapy induced nausea and vomiting. The standard triple drug regi
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histopathological confirmation of solid organ malignancy 2. Chemotherapy naive patients who need to be initiated highly emetogenic chemotherapy 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ?2 4. Patients who are eligible to receive chemotherapy that is having creatinine clearance >50ml/min, Platelets >1,00,000/cumm, normal auditory functions with no neurological deficits/ = CTCAE v5.0 Grade 2 peripheral neuropathy as assessed clinically. 5. Patients with Serum Aspartate or Alanine aminotransferase levels ? 3 upper normal limits, total bilirubin ? 1.5 times the upper normal limits 6. Patients with Absolute Neutrophil Count (ANC) = 1500/cumm 7. Patients with normal Left Ventricular Ejection Fraction (LVEF) = 50%, with no history of myocardial infarction/ cardiac arrhythmia in the past 6 months or less. 8. Patients having telephonic access
Exclusion criteria
Exclusion criteria: 1. Known previous history of hypersensitivity to Olanzapine or Mirtazapine. 2. History of poorly controlled diabetes (Glycated Hemoglobin >8) 3. Patients with symptomatic decompensated liver disease/ history of Hepatitis B/ C infection and receiving anti-viral medications for the same. 4. Patients with history of seizures or those with factors which may lower seizure threshold. 5. Patients on concomitant drugs which are known to cause prolongation of QTc ( >440ms in men and >460ms in women) 6. Female patients who are pregnant or lactating. 7. Use of MAO inhibitors within the past 14 days and patient taking antiemetic drug- Metoclopramide. 8. Patients with history or signs suggestive of middle ear pathology. 9. Patients not willing to consent for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Total Control of nausea and vomiting (TC) in the overall period after the administration of HEC between Mirtazapine and Olanzapine arms. Timepoint: The outcome will be assessed at 24 hours after chemotherapy, 120 hours after chemotherapy and at 4 weeks after the first cycle of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess Complete Response (CR) during the acute phase and the delayed phase and to study the impact on QoL due to CINV by the Functional Living Index Emesis (FLIE) questionnaire. 2. To study the safety profile of both the drugs and to enumerate and grade the adverse events occurring in the study population, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Timepoint: DAY 6 | — |
Countries
India
Contacts
Public ContactAnusha M
All India Institute of Medical Sciences Rishikesh
Outcome results
None listed