Patients with advanced cancer who experience chronic nausea and/or vomiting unrelated to chemotherapy may benefit from olanzapine treatment, according to a brief report published in JAMA Oncology. The authors of the pilot study warned that the small sample size may require prospective studies to compare results.
A team of researchers conducted a small, double-blind, randomized, placebo-controlled clinical trial (ClinicalTrials.gov Identifier: NCT03137121) to assess how successfully olanzapine could treat chronic nausea in patients with advanced cancer. Participants included outpatients with advanced cancer who did not receive any chemotherapy or radiation therapy in the 14 days prior to analysis but still experienced nausea for at least 1 week. Nausea was self-reported on a rating score that ranged from 0 to 10, where 10 was the most severe. Patients who rated their nausea with a score of 3 or higher were eligible for enrollment. The primary outcome measured changes in the patient-reported nausea rating scores.
A total of 30 participants (mean age, 63 years; 16 women) were included in the analysis; half of the cohort was treated with 5 mg of olanzapine for 7 days and the other half was treated with a placebo equivalent. At the start of the study, all patients rated their nausea as 9.
The placebo cohort reported a median score of 9 on both day 1 and 1 week after treatment, while patients in the olanzapine cohort reported a median score of 2 and 1 on day 1 and at 1 week, respectively. Patients treated with olanzapine reported an 8-point reduction in nausea after 1 week of treatment compared with patients treated with placebo.
Following the 7-day study, the protocol code was broken and patients were permitted to receive olanzapine prescriptions from their clinicians.
Months after protocol completion, the authors followed up with patients’ clinicians to determine how well patients were responding to treatment. Every patient from the olanzapine cohort continued treatment with continued efficacy and none reported toxicity due to olanzapine. In addition, 13 of the 14 patients from the placebo group who were offered olanzapine also started the treatment.
Within 3 to 12 weeks, the majority of patients who stopped treatment did so due to disease progression, inability to consume oral medications, and death.
“The small sample size in the current trial is clearly a study limitation,” the authors wrote. “Further data regarding the utility of olanzapine for controlling nausea and vomiting in patients with advanced cancer are welcomed.”
Navari RM, Pywell CM, Le-Rademacher JG, et al. Olanzapine for the treatment of advanced cancer–related chronic nausea and/or vomiting: a randomized pilot trial [published online May 7, 2020]. JAMA Oncol. doi: 10.1001/jamaoncol.2020.1052