Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Purpose
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.
Condition
- Advanced Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- There will be two groups for the study: Olanzapine Group will receive the study drug and Placebo Group will receive a placebo.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Patients will receive the study drug or placebo in a double-blind fashion.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Olanzapine |
Patients will receive 5 mg olanzapine orally for 1 to 7 days daily. |
|
|
Placebo Comparator Placebo |
Patients will receive a placebo orally for 1 to 7 days daily. |
|
More Details
- Status
- Completed
- Sponsor
- University of Alabama at Birmingham
Study Contact
Detailed Description
Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in >60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.