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

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ClinicalTrials.gov Identifier: NCT05403580
Recruitment Status : Recruiting
First Posted : June 3, 2022
Last Update Posted : January 6, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm Drug: Olanzapine Drug: Placebo Administration Other: Questionnaire Administration Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.

II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive olanzapine orally (PO) every night on days 1-28.

ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial
Actual Study Start Date : June 3, 2022
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (olanzapine)
Patients receive olanzapine PO every night on days 1-28.
 Drug: Olanzapine
Given PO
Other Names:
  • LY 170053
  • Zyprexa
  • Zyprexa Zydis

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm II (placebo, olanzapine)
Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
 Drug: Olanzapine
Given PO
Other Names:
  • LY 170053
  • Zyprexa
  • Zyprexa Zydis

Drug: Placebo Administration
Given PO

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Change in nausea score [ Time Frame: Baseline to 24 hours of treatment ]
    Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.


Secondary Outcome Measures :
  1. Daily nausea and vomiting scores [ Time Frame: Up to 28 days ]
    Chronic nausea this is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).

  2. Daily episodes of vomiting/retching (number and time) [ Time Frame: Up to 28 days ]
    Chronic nausea that is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).

  3. Utilization of rescue therapy [ Time Frame: Up to 28 days ]
    Baseline evaluation that includes assessment of symptom intensity for appetite, nausea, fatigue, sedation, and pain, all measured and recorded on a numeric rating score. (0 indicated the worst possible; 10, best possible).

  4. Incidence of adverse events with olanzapine [ Time Frame: Up to 28 days ]
    Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.


Eligibility Criteria
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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:

  • Age >= 18 years
  • Histologically or cytologically-confirmed cancer in an advanced incurable stage
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)
  • Serum creatinine < 2.0 mg/dl =< 120 days prior to registration
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) values < 3 times upper limits of normal =< 120 days prior to registration
  • Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only
  • Able to provide written informed consent
  • Able to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

  • Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:

    • Pregnant persons
    • Nursing persons
  • Received chemotherapy or radiation within the prior 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)
  • Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)
  • Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation

  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection (including human immunodeficiency virus [HIV])
    • Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Inability to swallow oral formulations of the agent(s)
  • Tube feeding or nasogastric tube
Contacts and Locations
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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): NCT05403580


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trial Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Charles L. Loprinzi, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles L Loprinzi Mayo Clinic in Rochester
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05403580    
Other Study ID Numbers: MC211002
NCI-2022-02478 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC211002 ( Other Identifier: Mayo Clinic in Rochester )
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
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