Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Advanced Cancer
In brief
The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.
Key facts
- Study ID
- NCT03137121
- Run by
- University of Alabama at Birmingham
- People needed
- 30
- Starts
- 2017-07-12
- Expected to finish
- 2020-09-15
- Last updated by the study team
- 2021-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be at least 18 years of age
- Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
- Have not received chemotherapy or radiation for >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)
- Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
- Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration
- Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration
- Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration.
You may not qualify if…
- Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
- Not have concurrent use of ethyol
- Not have severe cognitive compromise
- History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
- Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
- Chronic alcoholism (as determined by the investigator)
- Known hypersensitivity to olanzapine
- Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
- History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
- Planned chemotherapy or radiation during the 7 days following study initiation.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Indiana University — Indianapolis, Indiana, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Hospital Sisters Health System (HSHS) St. Vincent Hospital — Green Bay, Wisconsin, United States
Full record on ClinicalTrials.gov
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