Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting

Johns Hopkins University

Overview

Prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.

Patients will be identified who are seen in the Johns Hopkins Gastroenterology Clinic, suffer from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic medications, and are being prescribed olanzapine for treatment of nausea and vomiting. Patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of life, and psychological symptoms will be assessed by various questionnaires and followed over the course of 3 months.

Study Type

OBSERVATIONAL

Conditions

Nausea Vomiting

Interventions

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-65 years of age * Able to communicate in English without aid of interpreter * Have chronic refractory nausea, meeting each of the following criteria: 1. Baseline nausea and vomiting score on VAS of 25mm or greater 2. Duration symptoms of at least 6 months (does not have to be contiguous) 3. Intolerance to or inadequate response to prior treatment with both 1) ondansetron or another serotonin (5HT3) antagonist and 2) metoclopramide or domperidone Exclusion Criteria: * History of chemotherapy within the last year * Current diagnosis of cancer * Pregnant or breastfeeding * For females, active efforts to conceive/become pregnant during the time of the study * Chronic opioid use (3 times a week or greater use) * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of greater than 2x upper limit of normal (within 3 months of enrollment) * Cirrhosis * Unable or unwilling to stop using metoclopramide while using olanzapine * Concomitant use of other antipsychotics (e.g., haloperidol) * Prolonged corrected QT interval (QTc) (\>470ms for men and \>480ms for women) * History of life-threatening arrhythmia * Hypokalemia (potassium \<3.1) or hypomagnesemia (magnesium \<1.2) * Metabolic syndrome, defined as per Adult Treatment Panel III criteria * Granulocytopenia (absolute neutrophil count \<1500) * History of tardive dyskinesia * History of acute dystonic reaction to medications * History of neuroleptic malignant syndrome

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Nausea and vomiting severity

Effect of olanzapine on refractory nausea and vomiting as per changes in patient scoring of the severity of nausea and vomiting on a daily visual analog scale (VAS). Scores range from 0-100, with higher scores indicating more severe symptoms.

Time frame: 3 months

Secondary Outcomes

Severity of upper gastrointestinal symptoms

The effect of olanzapine on severity of upper gastrointestinal symptoms, assessed by the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales questionnaire. The questionnaire is 60-item GI symptom questionnaire covering 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Higher scores indicate more severe symptoms. A scoring service is used to convert the raw scores to a final T-score.

Time frame: 3 months

Quality of life and functional status

The effect of olanzapine on quality of life and functional status, assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.

Time frame: 3 months

Symptom-specific anxiety

The effect of olanzapine on patient's overall gastrointestinal symptom-specific anxiety, assessed by the Visceral Sensitivity Index (VSI) questionnaire. The VSI is an instrument to assess gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. The questionnaire consists of 15 questions, each scored 1-6. Total scores range from 15-90, with lower scores indicating more severe symptoms.

Data from ClinicalTrials.gov

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