Effects of Olanzapine on Chemotherapy‐Related Anxiety in Pediatric Cancer Patients: A Pilot Study

BACKGROUND: Anxiety is prevalent in children with cancer and can impair treatment adherence, outcomes, and quality of life. Chemotherapy often increases anxiety, potentially worsening complications like nausea, vomiting, and poor cooperation. This study investigated the efficacy of olanzapine in mitigating chemotherapy-induced anxiety in pediatric cancer patients. METHODS: This pilot randomized, double-blind, placebo-controlled trial enrolled pediatric patients with cancer. Participants were randomly assigned to receive either olanzapine or placebo, with one daily dose administered from 2 days prior to 3 days following chemotherapy, totaling five doses. Anxiety was measured at baseline, on the day of chemotherapy, and at the end of treatment using the Spence Children's Anxiety Scale (SCAS) and Visual Analog Scale (VAS) for anxiety; nausea and vomiting were graded per Common Terminology Criteria for Adverse Events (CTCAE). RESULTS: Between July 2024 and September 2025, 30 pediatric cancer patients (mean age 11.10 ± 2.59 years; 63% female) were enrolled and analyzed, with no significant demographic differences. SCAS scores showed a significant anxiety reduction in the olanzapine group post-intervention (p = 0.01) but not in the placebo group (p = 0.428). VAS anxiety scores did not differ significantly between groups, though the overall 5-day trend favored olanzapine. The olanzapine group also experienced improvements in nausea severity and vomiting frequency. Adverse effects were mild and transient. CONCLUSION: This pilot trial suggests that olanzapine may be both safe and effective in mitigating chemotherapy-related anxiety in pediatric cancer patients. These findings indicate its potential as an adjunct to current anxiety-management protocols. Further large-scale, confirmatory studies with extended follow-up are necessary to validate these results and evaluate long-term outcomes.