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

Primary Purpose

Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Olanzapine
Placebo Administration
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Malignant Solid Neoplasm

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm I (olanzapine)

    Arm II (placebo, olanzapine)

    Arm Description

    Patients receive olanzapine PO every night on days 1-28.

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

    Outcomes

    Primary Outcome Measures

    Change in nausea score
    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

    Daily nausea and vomiting scores
    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).
    Daily episodes of vomiting/retching (number and time)
    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).
    Utilization of rescue therapy
    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).
    Incidence of adverse events with olanzapine
    Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.

    Full Information

    First Posted
    May 19, 2022
    Last Updated
    August 14, 2023
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05403580
    Brief Title
    Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Closed due to slow accrual
    Study Start Date
    June 3, 2022 (Actual)
    Primary Completion Date
    February 15, 2024 (Anticipated)
    Study Completion Date
    February 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    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
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I (olanzapine)
    Arm Type
    Experimental
    Arm Description
    Patients receive olanzapine PO every night on days 1-28.
    Arm Title
    Arm II (placebo, olanzapine)
    Arm Type
    Active Comparator
    Arm Description
    Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
    Intervention Type
    Drug
    Intervention Name(s)
    Olanzapine
    Other Intervention Name(s)
    LY 170053, Zyprexa, Zyprexa Zydis
    Intervention Description
    Given PO
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Administration
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Change in nausea score
    Description
    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.
    Time Frame
    Baseline to 24 hours of treatment
    Secondary Outcome Measure Information:
    Title
    Daily nausea and vomiting scores
    Description
    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).
    Time Frame
    Up to 28 days
    Title
    Daily episodes of vomiting/retching (number and time)
    Description
    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).
    Time Frame
    Up to 28 days
    Title
    Utilization of rescue therapy
    Description
    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).
    Time Frame
    Up to 28 days
    Title
    Incidence of adverse events with olanzapine
    Description
    Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.
    Time Frame
    Up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles L Loprinzi
    Organizational Affiliation
    Mayo Clinic in Rochester
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

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

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