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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05403580
Collaborator
National Cancer Institute (NCI) (NIH)
20
1
2
20.4
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Olanzapine
  • Drug: Placebo Administration
  • Other: Questionnaire Administration
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.

  2. 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

Study Type:
Interventional
Anticipated 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 :
Jun 3, 2022
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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

    Primary Outcome Measures

    1. Change in nausea score [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 [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) [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 [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 [Up to 28 days]

      Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Charles L Loprinzi, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05403580
    Other Study ID Numbers:
    • MC211002
    • NCI-2022-02478
    • MC211002
    • P30CA015083
    First Posted:
    Jun 3, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 6, 2022