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

Primary Purpose

Advanced Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring nausea, vomiting, olanzapine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be at least 18 years of age
  • Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
  • Have not received chemotherapy or radiation for >14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
  • Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
  • Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration
  • Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration
  • Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration.

Exclusion Criteria:

  • Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
  • Not have concurrent use of ethyol
  • Not have severe cognitive compromise
  • History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
  • Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
  • Chronic alcoholism (as determined by the investigator)
  • Known hypersensitivity to olanzapine
  • Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
  • History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
  • Planned chemotherapy or radiation during the 7 days following study initiation.

Sites / Locations

  • University of Alabama at Birmingham
  • Indiana University
  • Mayo Clinic
  • Washington University School of Medicine
  • Hospital Sisters Health System (HSHS) St. Vincent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olanzapine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Nausea Scores
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.

Secondary Outcome Measures

Number of Emetic Episodes
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.
Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".
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.

Full Information

First Posted
April 25, 2017
Last Updated
July 23, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03137121
Brief Title
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Official Title
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in >60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
Keywords
nausea, vomiting, olanzapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups for the study: Olanzapine Group will receive the study drug and Placebo Group will receive a placebo.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Patients will receive the study drug or placebo in a double-blind fashion.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a placebo orally for 1 to 7 days daily.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
Olanzapine is used as an anti-emetic.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo is a non-anti-emetic.
Primary Outcome Measure Information:
Title
Mean Nausea Scores
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.
Secondary Outcome Measure Information:
Title
Number of Emetic Episodes
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.
Title
Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage Have not received chemotherapy or radiation for >14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible) Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration. Exclusion Criteria: Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy) Not have concurrent use of ethyol Not have severe cognitive compromise History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder) Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy Chronic alcoholism (as determined by the investigator) Known hypersensitivity to olanzapine Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted) Planned chemotherapy or radiation during the 7 days following study initiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolph Navari, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital Sisters Health System (HSHS) St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32379269
Citation
Navari RM, Pywell CM, Le-Rademacher JG, White P, Dodge AB, Albany C, Loprinzi CL. Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial. JAMA Oncol. 2020 Jun 1;6(6):895-899. doi: 10.1001/jamaoncol.2020.1052.
Results Reference
derived

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

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