Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care

NCT03679182 | Unknown Phase 2

• 1 other identifier: HE591547
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Oral olanzapine showed superior antiemetic efficacy to metoclopramide as rescue treatment to control breakthrough emesis induced by chemotherapy. This study aims to evaluate safety and efficacy of olanzapine for nausea and vomiting in advanced cancer patients.

Conditions

Nausea; Vomiting; End Stage Cancer

Outcome Measures

Primary Outcomes (1)

• Emesis control

  Percentage of patients without emesis

  48 hours

Study Arms (1)

Olanzapine

EXPERIMENTAL

Olanzapine 5 mg at 0, 12, 24 and 36 hours

Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours

Also known as: olanzapine 5 mg Tab

Olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years.
• Diagnosis of advanced malignancy.
• Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
• Adequate organ function, including the following:
• Hepatic: bilirubin ≤1.5 times the upper limit of normal (x ULN); aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement), alkaline phosphatase (AP) ≤5.0 x ULN.
• Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
• Expected life expectancy \> 1 month.
• Patients must be able to read Thai.
• Patients must sign an informed consent document.

You may not qualify if:

• Patients with history of abdominal radiotherapy.
• Patients who receive chemotherapy within 1 week.
• Patients who take fluoxetine.
• Patients with heart failure or myocardial infarction in the past 6 months.
• Patients with QTc prolongation from baseline ECG.
• Known hypersensitivity to olanzapine.
• Patients who are unwilling to participate in the study.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Jarin Chindaprasirt

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Attakorn Raksasataya, MD

  Khon Kaen University

  STUDY DIRECTOR

Central Study Contacts

Jarin Chindaprasirt, MD

CONTACT

+66846831097; jarich@kku.ac.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

TH (1)