Clinical trial NCT03137121: Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients
Official title: Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Advanced Cancer
Keywords: nausea
vomiting
olanzapine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2017-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Nausea Scores
timeFrame: Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.
Secondary outcomes:
measure: Number of Emetic Episodes
timeFrame: Number of emetic episodes for each patient on each day of the seven day treatment.
measure: Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".
timeFrame: Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Green Bay
country: United States
facility: Hospital Sisters Health System (HSHS) St. Vincent Hospital
state: Wisconsin
Study officials:
affiliation: University of Alabama at Birmingham
name: Rudolph Navari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navari RM, Pywell CM, Le-Rademacher JG, White P, Dodge AB, Albany C, Loprinzi CL. Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial. JAMA Oncol. 2020 Jun 1;6(6):895-899. doi: 10.1001/jamaoncol.2020.1052.