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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

NCT06850454

Chemotherapy Induced Nausea and Vomiting

RECRUITING PHASE3

Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study

NCT04536558

Solid Tumor Patients Receiving High Emetic Risk Multi-day Chemotherapy

UNKNOWN PHASE3

Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

NCT03876938

Antiemetic for Highly Emetogenic Chemotherapy

UNKNOWN PHASE3

Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer

NCT04669132

Nausea Post Chemotherapy

COMPLETED PHASE2

Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy of Lung Cancer

NCT03571126

Chemotherapy-induced Nausea and Vomiting Lung Cancer

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a pilot study; open-label prospective clinical trial. Oral olanzapine 5 mg tablet will be given to patients who fail two standard treatment medications for nausea and vomiting within 30 minutes after the first vomiting episode. Other doses of olanzapine will be given at 12, 24, and 36 hours following the first dose concurrently with standard regimen.

Patients with emesis will be followed up after receiving olanzapine every 12 hour for 48 hours. We will record the frequency of vomiting, nausea, and retching.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Vomiting End Stage Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olanzapine

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

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olanzapine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

olanzapine 5 mg Tab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18-65 years.
2. Diagnosis of advanced malignancy.
3. Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
4. Adequate organ function, including the following:

1. 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.
2. Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
5. Expected life expectancy \> 1 month.
6. Patients must be able to read Thai.
7. Patients must sign an informed consent document.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No