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

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Registration - Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically-confirmed cancer in an advanced incurable stage.
  • 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 and SGOT (AST) or SGPT (ALT) values < 3 times upper limits of normal, ≤ 120 days prior to registration.
  • Negative pregnancy test done ≤ 7 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.

Registration - 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 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.

Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions