Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Olanzapine 5mg plus Pregabalin 50mg: capsules Olanzapine contains 5mg olanzapine and capsules of Pregabalin contains 50mg pregabalin dose- 1 capsule of each drug will be given 1hour bef
Sponsors
Anand Srinivasan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cancer patients with Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 who have been planned to receive a highly emetogenic cancer chemotherapy regimen like high dose cisplatin or anthracycline combined with cyclophosphamide (AC) regimen. 2. Participants with primary education qualifications who are willing to give written informed consent. 3. Participants who can swallow the study drugs.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of nausea or vomiting or who received another antiemetic treatment regimen within 24 hours before enrolment. 2. Patients with renal impairment 3.Patients with hepatic impairment 4.Patients with a serum pottasium value of less than 3.5 5.Patients with history of CNS malignancies or metastases. 6.Patients with active infection, fever, gastrointestinal obstruction,history of bleeding disorders, coagulopathy, active or latent tuberculosis, fungal infections, HIV, immune deficiency disorders, history of congenital long QT syndrome, QT interval prolongation, cardiac arrhythmias, conduction disorders, narrow-angle glaucoma, cardiovascular diseases (cardiac failure, myocardial infarction), severe hypertension ,insulin-dependent or uncontrolled diabetes mellitus or osteoporosis. 7. Patients with neutropenia , anemia, or thrombocytopenia 8. Concurrent use of serotoninergic medications like SSRI , SNRI triptans , monoamine oxidase inhibitors , trazodone, mirtazapine, vilazodone, vortioxetine etc. 9.Concurrent use of dopaminergic drugs like bromocriptine, cabergoline, ropinirole, pramipexole, metoclopramide, promethazine, chlorpromazine, amantadine, levodopa, domperidone etc 10.. Concurrent use of anticonvulsants, sedatives, medications with emetogenic potential other than that included in chemotherapeutic regime or anticoagulants. 11 Patients with a lack of compliance, inability to follow study procedures, history of substance abuse, addiction, or who are unable to provide informed consent 12. Patients with known hypersensitivity to study medications or with a history of long-term use of any of the study drugs 13. Patients with recent use of live or attenuated vaccines 14. History of concurrent radiation therapy, stem cell transplantation. 15. Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the non-inferiority of add-on pregabalin and olanzapine-containing regimen vs. add-on aprepitant-containing regimen in the management of nausea associated with CINV in terms of overall visual analog scale (VAS) score over the period of 5 days.Timepoint: Days 1 to 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the difference in the percentage of patients with no nausea in acute(less than 24 hours), delayed(24 hours-5 days), and overall periods between study groups.Timepoint: Days 1 to 5;To determine the difference in the percentage of patients with no vomiting in the acute, delayed, and overall period between the study groups.Timepoint: Days 1 to 5;To determine the difference in the percentage of patients with no significant nausea (VAS less than or equal to 25mm) in the acute, delayed, and overall period between the study groups. Timepoint: Days 1 to 5;To determine the difference in the percentage of patients with complete response (no vomiting episodes and no use of rescue medication) in the acute, delayed, and overall period between the study groups.Timepoint: Days 1 to 5;To determine the difference in the percentage of patients with complete control (no nausea, no vomiting, no use of rescue medication) in the acute, delayed, and overall periods between the study groups.Timepoint: Days 1 to 5;To determine the difference in rescue medication usage in the acute, delayed, and overall period between the study groups.Timepoint: Days 1 to 5;To compare quality of life using the Functional Living Index-Emesis(FLIE) questionnaire among both study groupsTimepoint: Days 1 to 5;To monitor the overall treatment-emergent and treatment-specific adverse events (AE) such as undesired sedation, visual disturbance, change in appetite pattern, postural hypotension, constipation, and others between the study groups.Timepoint: Days 1 to 5 | — |
Countries
India
Contacts
Public ContactArchana AS
AIIMS Bhubaneswar
Outcome results
None listed