Naomi Mizukami1, Masanori Yamauchi2, Kazuhiko Koike3, Akihiko Watanabe2, Koji Ichihara4, Naoya Masumori4, Michiaki Yamakage2. 1. Department of Anesthesiology, Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan. Electronic address: nao.nao910@aurora.ocn.ne.jp. 2. Department of Anesthesiology, Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan. 3. Division of Palliative Medicine, Higashi-Sapporo Hospital, Sapporo, Hokkaido, Japan. 4. Department of Urologic Surgery and Andrology, Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan.
Abstract
CONTEXT: Chemotherapy-induced nausea and vomiting (CINV) can severely impair patients' quality of life (QOL). Psychotropics, especially olanzapine, have a strong antiemetic effect. OBJECTIVES: To determine whether olanzapine could reduce the frequency of CINV and improve patients' QOL during chemotherapy. METHODS: This was a randomized, double-blind, placebo-controlled trial. Forty-four patients scheduled to receive highly or moderately emetogenic chemotherapy were enrolled. All patients received a 5-hydroxytryptamine3 receptor antagonist, steroid, and neurokinin-1 receptor antagonist. Patients were randomly assigned to take 5 mg/day of oral olanzapine (OL group, n = 22) or placebo (control group, n = 22) daily from the day before chemotherapy (Day 0) to Day 5. The primary endpoint was the rate of patients who achieved total control (no vomiting, no use of rescue medications, and maximum nausea of <5/100mm on a visual analogue scale). The secondary endpoint was Functional Living Index-Emesis questionnaire score on Days 0 and 6. RESULTS: The rate of patients achieving total control was significantly higher in the OL group (86% and 64% in acute and delayed phases, respectively) than in the control group (55% and 23%, P = 0.045, P = 0.014, respectively). Furthermore, the OL group experienced a better QOL than the control group, as reported on the Functional Living Index-Emesis questionnaire (P = 0.0004). CONCLUSION: The addition of 5mg/day of oral olanzapine to standard therapy can reduce the frequency of CINV and improve QOL of patients receiving highly or moderately emetogenic chemotherapy.
RCT Entities:
CONTEXT: Chemotherapy-induced nausea and vomiting (CINV) can severely impair patients' quality of life (QOL). Psychotropics, especially olanzapine, have a strong antiemetic effect. OBJECTIVES: To determine whether olanzapine could reduce the frequency of CINV and improve patients' QOL during chemotherapy. METHODS: This was a randomized, double-blind, placebo-controlled trial. Forty-four patients scheduled to receive highly or moderately emetogenic chemotherapy were enrolled. All patients received a 5-hydroxytryptamine3 receptor antagonist, steroid, and neurokinin-1 receptor antagonist. Patients were randomly assigned to take 5 mg/day of oral olanzapine (OL group, n = 22) or placebo (control group, n = 22) daily from the day before chemotherapy (Day 0) to Day 5. The primary endpoint was the rate of patients who achieved total control (no vomiting, no use of rescue medications, and maximum nausea of <5/100mm on a visual analogue scale). The secondary endpoint was Functional Living Index-Emesis questionnaire score on Days 0 and 6. RESULTS: The rate of patients achieving total control was significantly higher in the OL group (86% and 64% in acute and delayed phases, respectively) than in the control group (55% and 23%, P = 0.045, P = 0.014, respectively). Furthermore, the OL group experienced a better QOL than the control group, as reported on the Functional Living Index-Emesis questionnaire (P = 0.0004). CONCLUSION: The addition of 5mg/day of oral olanzapine to standard therapy can reduce the frequency of CINV and improve QOL of patients receiving highly or moderately emetogenic chemotherapy.
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