Prospective study on olanzapine for prevention of radiotherapy induced nausea and vomiting
Phase 3
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2022/01/039723
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients aged 18 years or older
Radiotherapy naive patients
Patients receiving abdominal or pelvic radiotherapy
Patients or their care givers willing to provide informed signed consent
Exclusion Criteria
Patients who received less than 15 fractions of radiation therapy
Patients with history of brain metastasis & seizure disorder
Patients receiving antipsychotic drugs within a window period of 30 days prior radiation therapy
Elderly patients with dementia-related psychosis .
Patients with uncontrolled diabetes mellitus
Patients with drug abuse
Allergic to any of the study medications
Patients already on systemic corticosteroids
Vomiting within the last 24hrs, prior to radiotherapy
Previous history of nausea.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete control of emesis (No emesis and no rescue therapy during the entire study period)Timepoint: Baseline to end of radiotherapy
- Secondary Outcome Measures
Name Time Method Complete control of nausea (No nausea and no rescue therapy during the entire study period)Timepoint: Baseline to end of radiotherapy