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A study to compare benefits of Olanzapine 5mg over Olanzapine 10mg for prevention of nausea and vomiting caused by anticancer medicines.

A Randomized, Open Label Trial to Compare Efficacy and Safety of Olanzapine 10mgand 5mg for the prophylaxis of emesis in patients receiving highly emetogenic cancer chemotherapy - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066232
Enrollment
98
Registered
2024-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Tablet Olanzapine 5mg: 1st day of anticancer chemotherapy- Tablet Olanzapine 5mg Once a day before chemo administration and regimen (Injection palonosetron 0.25mg once a day, Injection

Sponsors

Department of Pharmacology and Department of RadioOncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-18 years of age or older patients who had not received previous chemotherapy 2-Patients going to receive 1st cycle of highly emetogenic cancer chemotherapy 3-Written informed consent. 4-Able to understand and describe patient-reported outcomes.

Exclusion criteria

Exclusion criteria: 1-History of hypersensitivity or allergy to any of antiemetic drugs we are going to use in study 2-Received any chemotherapy in last 3 weeks. 3-Multiday chemotherapy regimen, concurrent radiotherapy 4-brain metastasis

Design outcomes

Primary

MeasureTime frame
primary outcome- complete response of vomiting in early(0- 24hrs), delayed(24-120 hrs) in both groups Secondary outcome- to record different grades of chemotherapy induced nausea and vomiting in all three periodsTimepoint: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)

Secondary

MeasureTime frame
To record different grades of chemotherapy induced nausea and vomiting (CINV) in all three periods: - Acute (0- 24 hrs), Delayed (24 -120hrs), overall(0-120hrs).Timepoint: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)

Countries

India

Contacts

Public ContactDr Abhay Pratap Singh

UPUMS, Saifai

alkdxt@yahoo.co.in9639523852

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026