Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Olanzapine 5mg plus Pregabalin 75mg: capsules Olanzapine contains 5mg olanzapine and capsules of Pregabalin contains 75mg 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 (0-indicates no symptoms and 5-indicates increasing disability) who have been planned to receive a highly emetogenic cancer chemotherapy regimens like high dose cisplatin or anthracycline combined with cyclophosphamide (AC) regimen 2. Participants who have primary education qualifications and who are willing to give written informed consent. 3. Participants who can swallow the experimental drugs.
Exclusion criteria
Exclusion criteria: 1.History of nausea or vomiting within 24 hours before enrolment. 2.Patients who have received another antiemetic treatment regimen within 24 hours prior to the first chemotherapy dose. 3.Elevated lab parameters such as serum creatinine level of more than 2.0 mg per decilitre, aspartate or alanine aminotransferase level greater than three times the normal upper limit, and absolute neutrophil count less than 1500 per mm3. 4.Patients with either primary or secondary CNS malignancy. 5.Patients with a history of central nervous system (CNS) disease such as seizure disorder, Parkinson disease, psychiatric illness, and severe cognitive compromise. 6.Patients with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue), apomorphine, amphotericin B, macrolide antibiotics, warfarin, cyclosporine, OCP, ketoconazole, aspirin, tolbutamide, or who are on treatment with any antipsychotic agent within 30 days of enrolment or planned to receive them during the study period. 7.Patients with routine administration of vaccines or toxoids should be deferred. 8.Patients with systemic fungal infections. 9.Patient with a known history of hypersensitivity to ondansetron, dexamethasone, aprepitant, olanzapine, pregabalin, or their components. 10.Patients who are planned to receive concurrent radiotherapy which will be coinciding with the chemotherapy cycles. 11.Patients with a known history of uncontrolled congestive heart failure, cardiac arrhythmia, or acute myocardial infarction events. 12.Patients following abdominal surgery within the previous six months. 13.Patient with uncontrolled diabetes mellitus. 14.Patients with conditions causing upper gastrointestinal tract obstruction as per radiological findings. 15.Patients with metabolic disorders (such as hypercalcemia, hyperglycaemia or hyponatremia, and uraemia causing nausea and vomiting). 16.Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the non-inferiority of olanzapine and pregabalin-containing regimen against the aprepitant-containing regimen in terms of average overall nausea as measured by visual analogue scale (VAS) score over a period of 5 days post highly emetogenic chemotherapy administration to cancer patient.Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the difference in nausea rating in terms of VAS scores in acute, delayed and overall periods.Timepoint: 5 days;To determine the difference in the percentage of patients with complete response (no nausea/vomiting without any rescue medication) in the acute period (0 hrs to 24 hrs of post-chemotherapy), delayed (24hrs to 5 days) period and over all periodTimepoint: 5 days;To determine the difference in the percentage of patients with no nausea in the acute (0 hrs to 24 hrs of post-chemotherapy) period, delayed (24hrs to 5 days) period.Timepoint: 5 days;To determine the difference in the percentage of patients with no significant nausea (VAS = 25mm) in acute (0 hrs to 24 hrs of post-chemotherapy) period, delayed (24hrs to 5 days) period and over all periodTimepoint: 5 days;To determine the difference in the usage of rescue medication between both the groupsTimepoint: 5 days;To measure the effectiveness of the intervention on improvement of patient quality of life using the FLIE questionnaireTimepoint: 5 dyas;To monitor the overall treatment-emergent adverse events and treatment specific adverse events such as undesired sedation, appetite, and difficulty in visionTimepoint: 5 days | — |
Countries
India
Contacts
Public ContactDivya V
AIIMS Bhubaneswar
Outcome results
None listed