Health Condition 1: R112- Nausea with vomiting, unspecified
Conditions
Interventions
Intervention1: OPF arm: Patients in the OPF arm (study arm) to receive tablet olanzapine 5 mg orally, IV palonosetron 0.25 mg, and IV fosaprepitant 150 mg
. Olanzapine 5 mg orally once a day will be c
Sponsors
Department of Medical Oncology, Goa Medical College, Bambolim, Goa
Eligibility
Inclusion criteria
Inclusion criteria: 1) Chemotherapy naive patients, planned for 1st cycle of HEC 2) Age 18 to 99 years 3) Eastern Cooperative Oncology Group performance status less than or equal to 2 4) Absence of nausea and vomiting 24 hours before enrollment 5) Adequate organ function 6) No severe alcohol use disorder as per DSM 5
Exclusion criteria
Exclusion criteria: 1) Patients receiving steroids as part of a chemotherapy regimen or premedication. 2) Multiday chemotherapy 3) Patients in whom steroids are contraindicated (uncontrolled DM and HTN). 4) Patients with brain primary malignancy and brain metastasis. 5) Treatment with another antipsychotic agent for 30 days before or during the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR) of Chemotherapy induced nausea and vomiting at 0 to 120 hours post-chemotherapy. Complete response is no emesis and no use of rescue antiemetics within the assessment periodTimepoint: Acute phase: 0 24 hours post-chemotherapy Delayed phase: 24 120 hours post-chemotherapy Overall phase: 0 120 hours post-chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Nausea (Patient-Reported Outcomes) at 0 120 hours post-chemotherapy. Measured using a validated nausea scaleTimepoint: Acute (0 24h), Delayed (24 120h), Overall (0 120h);Requirement for Breakthrough Antiemetic Medications. Proportion of patients needing additional antiemetics post-chemotherapyTimepoint: 0-120 hours | — |
Countries
India
Contacts
Public ContactDr Jivan Babulal Jain
Goa Medical College and Hospital, Goa
Outcome results
None listed