Clinical Trials

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.