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

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ClinicalTrials.gov Identifier: NCT03137121
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : August 17, 2021
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Rudolph Navari, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Advanced Cancer
Interventions Drug: Olanzapine
Other: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

Period Title: Overall Study
Started 15 15
Completed 15 14
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Olanzapine Placebo Total
Hide Arm/Group Description

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
63  (9) 60  (11) 62  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
8
  53.3%
9
  60.0%
17
  56.7%
Male
7
  46.7%
6
  40.0%
13
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
15
 100.0%
30
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  33.3%
6
  40.0%
11
  36.7%
White
10
  66.7%
9
  60.0%
19
  63.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Mean Nausea Scores
Hide Description

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 the same time each day to remind the patient to record the nausea score and to inquire about any toxicities. The difference in the nausea scores for the patients in each group (Olanzapine and Placebo) will be compared.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient withdrew on their own from the Placebo Group
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description:

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (1) 9  (2)
2.Secondary Outcome
Title Number of Emetic Episodes
Hide Description 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.
Time Frame Number of emetic episodes for each patient on each day of the seven day treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient withdrew from the Placebo Group.
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description:

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: episodes
day 1 3 3
day 2 0 3
day 3 0 3
day 4 0 3
day 5 0 3
day 6 0 3
day 7 0 3
3.Secondary Outcome
Title Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".
Hide Description 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.
Time Frame Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient withdrew from Placebo Group.
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description:

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: Events
3 21
Time Frame from baseline through 8 days
Adverse Event Reporting Description One patient withdrew from Placebo Group.
 
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Olanzapine: Olanzapine is used as an anti-emetic.

Patients will receive a placebo orally for 1 to 7 days daily.

Placebo: The placebo is a non-anti-emetic.

All-Cause Mortality
Olanzapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Olanzapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olanzapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      6/14 (42.86%)    
Gastrointestinal disorders     
Nausea   3/15 (20.00%)  3 6/14 (42.86%)  21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rudolph M Navari
Organization: Univ Alabama Birmingham
Phone: 574-261-8385
EMail: rmnavari@gmail.com
Layout table for additonal information
Responsible Party: Rudolph Navari, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03137121    
Other Study ID Numbers: F170104006 (XUAB 16100)
000515449 ( Other Identifier: UAB Office of Sponsored Programs )
First Submitted: April 25, 2017
First Posted: May 2, 2017
Results First Submitted: August 13, 2020
Results First Posted: August 17, 2021
Last Update Posted: August 17, 2021