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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 : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Rudolph Navari, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Olanzapine Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two groups for the study: Group 1 will receive the study drug and Group 2 will receive a placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients will receive the study drug or placebo in a double-blind fashion.
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2017
Actual Primary Completion Date : July 12, 2019
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.
Drug: Olanzapine
Olanzapine is used as an anti-emetic.
Other Name: Zyprexa

Placebo Comparator: Group 2
Patients will receive a placebo orally for 1 to 7 days daily.
Other: Placebo
The placebo is a non-anti-emetic.




Primary Outcome Measures :
  1. Effect of olanzapine [ Time Frame: Nausea score from the Visula Analogue Scale will be recorded each day daily for 7 days ]
    Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from Groups 1 and 2 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. 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 (Group 1 and Group 2) will be compared.


Secondary Outcome Measures :
  1. Effect of Olanzapine [ Time Frame: 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 (1 and 2) 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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". [ Time Frame: Daily assessment for 7 days for each patient in Groups 1 and 2 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 SGOT or SGPT < 3 times upper limits of normal ≤120 days prior to registration
  • 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 prochloperazine and other phenothiazines as prior anti-emetic therapy)
  • Not have concurrent use of ethyol
  • Not have severe cognitive compromise
  • History of 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137121


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
Hospital Sisters Health System (HSHS) St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
University of Alabama at Birmingham
Mayo Clinic
Investigators
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Principal Investigator: Rudolph Navari, MD University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rudolph Navari, Professor, 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 Posted: May 2, 2017    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rudolph Navari, University of Alabama at Birmingham:
nausea
vomiting
olanzapine
Additional relevant MeSH terms:
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Neoplasms
Nausea
Vomiting
Signs and Symptoms, Digestive
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents