Steroid Free anti emetic combinatio

Phase 2

Completed

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2021/09/036663
• Lead Sponsor: CI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-20
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 82

Inclusion Criteria

Diagnosis of malignancy

No prior chemotherapy and radiation therapy (RT)

Age of >= 18 â?? up to 65 years

ECOG Performance status (0-2)

Complete hemogram (ANC >=1000/m3, TLC >=3000/m3, Platelets >= 1,00,000/m3), Creatinine (<= 2 mg/dl), SGOT / SGPT (<= 3 X ULN, Bilirubin <2.0 mg/dl)

First cycle of moderately emetogenic chemotherapy defined as

Oxaliplatin at dose >=80mg/m2 with or without other agents

Willing to give written informed consent for the study participation

Exclusion Criteria

Patient receiving concurrent psychiatric drugs (clozapine, risperidone, quetiapine, phenothiazine etc), CNS depressants (azelastine, bromopride, bromperidol, buprenorphine), anti-Parkinson drugs (dopamine agonist), benzodiazepines, cabergoline, anti-cholinergic (glycopyrrolate, ipratropium, levosulpiride, potassium chloride, potassium citrate etc), metoclopramide, pimozide, quinolone, amifostine

Hypersensitivity to any of the drugs used in the study {Olanzapine, 5-HT3 antagonist â?? Ondansetron}

On systemic steroids

History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis

Symptomatic Brain metastasis / Carcinomatous Meningitis

History of nausea and vomiting in 24 hours prior to first dose of chemotherapy

Use of anti-emetic drugs (5-HT3 Antagonist) in last 24 hours

Started on opioids in last 48 hours

Female who is pregnant, or breast-feeding his children

Patients with dementia related psychosis or psychiatric disorder

No concurrent abdominal radiotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapyTimepoint: To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy

Secondary Outcome Measures

Name	Time	Method
To determine the rate of complete response ((no emesis, no use of rescue medications) during the acute period (0-24 hours), delayed period (24 â?? 120 hours) <br/ ><br>To determine the rate of nausea control assessed by â??Edmontonsymptomassessment scaleâ?? (ESAS) during the acute period (0-24 hours), delayed period (24 â?? 120 hours) and overall period (0-120 hours) <br/ ><br>To determine the rate of complete control during the overall period (0-120 hours) <br/ ><br>To determine the rate of total control during the overall period (0-120 hours) <br/ ><br>Toxicity pattern and incidence <br/ ><br>Time to treatment failure <br/ ><br>Prognostic factors associated with CINV controlTimepoint: 5-7 days