NCT03137121

Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

Completed Phase 2, PHASE3 Results posted Last updated 17 August 2021

What this trial tests

Phase 2, PHASE3 trial testing Olanzapine in Advanced Cancer in 30 participants. Completed in 15 September 2020.

Timeline

12 July 2017

Primary endpoint
12 July 2019

15 September 2020

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	12 July 2017
Primary completion	12 July 2019
Estimated completion	15 September 2020
Sites	5 locations across United States

Drugs / interventions tested

• Olanzapine (olanzapine) — full drug profile →
• Placebo

Conditions studied

• Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Nausea Scores Primary · Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.

Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from the Olanzapine and Placebo group will be measured using the Visual Analogue Scale rankings from 0-10 where 0 is no nausea and 10 is the maximum nausea experienced by a patient. A Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that can't be directly measured. Patients will be asked to record the average nausea score for each day in a diary and a study nurse will call the patient at th

Group	Value	95% CI
Olanzapine	1	± 1
Placebo	9	± 2

Number of Emetic Episodes Secondary · Number of emetic episodes for each patient on each day of the seven day treatment.

The number of emetic episodes (a secondary outcome) by each patient in each group, Olanzapine \& Placebo, on each day of treatment will be recorded by each patient on each day of treatment in a diary. A study nurse will contact each patient at the same time of each day of the study to ask the patient to record the number of emetic episodes and report any toxicities.The number of emetic episodes for the patients in each Group for each day of the treatment will be compared.

day 1

Group	Value	95% CI
Olanzapine	3
Placebo	3

day 2

Group	Value	95% CI
Olanzapine	0
Placebo	3

day 3

Group	Value	95% CI
Olanzapine	0
Placebo	3

day 4

Group	Value	95% CI
Olanzapine	0
Placebo	3

day 5

Group	Value	95% CI
Olanzapine	0
Placebo	3

day 6

Group	Value	95% CI
Olanzapine	0
Placebo	3

day 7

Group	Value	95% CI
Olanzapine	0
Placebo	3

Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0". Secondary · Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.

Adverse events will be measured by patient-reported outcomes questionnaires and the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A study nurse will contact each patient each day of the seven days of treatment to inquire about any toxicities, specifically sedation and appetite. Sedation and appetite will be reported by the patient in each Group on a Visual Analogue Scale of 0 to 10 with 0 being no sedation or no appetite to 10 indicating maximum sedation or maximum appetite.

Group	Value	95% CI
Olanzapine	3
Placebo	21

Adverse events — posted to ClinicalTrials.gov

Time frame: from baseline through 8 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Olanzapine

Serious: 0/15 (0%)

Deaths: 0/15

Placebo

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (1 terms — click to expand)

Reaction	System	Olanzapine	Placebo
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03137121 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial.
   Navari RM, Pywell CM, Le-Rademacher JG, White P, et al · · 2020 · cited 46× · PMID 32379269 · DOI 10.1001/jamaoncol.2020.1052
2. Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults.
   Sutherland A, Naessens K, Plugge E, Ware L, et al · · 2018 · cited 40× · PMID 30246876 · DOI 10.1002/14651858.cd012555.pub2