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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 19, 2022
First Posted Date  ICMJE June 3, 2022
Last Update Posted Date January 6, 2023
Actual Study Start Date  ICMJE June 3, 2022
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2022)
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Advanced Malignant Solid Neoplasm
  • Hematopoietic and Lymphoid Cell Neoplasm
Intervention  ICMJE
  • Drug: Olanzapine
    Given PO
    Other Names:
    • LY 170053
    • Zyprexa
    • Zyprexa Zydis
  • Drug: Placebo Administration
    Given PO
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (olanzapine)
    Patients receive olanzapine PO every night on days 1-28.
    Interventions:
    • Drug: Olanzapine
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Drug: Olanzapine
    • Drug: Placebo Administration
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2024
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05403580
Other Study ID Numbers  ICMJE MC211002
NCI-2022-02478 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC211002 ( Other Identifier: Mayo Clinic in Rochester )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Charles L Loprinzi Mayo Clinic in Rochester
PRS Account Mayo Clinic
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP