This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
PRIMARY OBJECTIVE: I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting. SECONDARY OBJECTIVES: I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting. II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive olanzapine orally (PO) every night on days 1-28. ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Change in nausea score
Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.
Time frame: Baseline to 24 hours of treatment
Daily nausea and vomiting scores
Chronic nausea this is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
Time frame: Up to 28 days
Daily episodes of vomiting/retching (number and time)
Chronic nausea that is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
Time frame: Up to 28 days
Utilization of rescue therapy
Baseline evaluation that includes assessment of symptom intensity for appetite, nausea, fatigue, sedation, and pain, all measured and recorded on a numeric rating score. (0 indicated the worst possible; 10, best possible).
Time frame: Up to 28 days
Incidence of adverse events with olanzapine
Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 28 days
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