Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

Summary

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.

Timeline

Start

2023-04-15

Primary completion

2024-04-30

Completion

2024-05-15

Publications

• Results Ng TL, Hutton B, Clemons M. Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea? Oncologist. 2015 Jun;20(6):576-83. doi: 10.1634/theoncologist.2014-0438. Epub 2015 May 6.
• Results Yang LQ, Sun XC, Qin SK, Cheng Y, Shi JH, Chen ZD, Wang QM, Zhang HL, Hu B, Liu B, Zhang QY, Wu Q, Wang D, Shu YQ, Dong J, Han BH, Wang KM, Dang CX, Li JL, Wang HB, Li BL, Lu JG, Zhang ZH, Chen YX. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017 Nov;26(6):e12668. doi: 10.1111/ecc.12668. Epub 2017 Apr 10.
• Results Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.
• Results Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
• Results Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.
• Results Chelkeba L, Gidey K, Mamo A, Yohannes B, Matso T, Melaku T. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. Pharm Pract (Granada). 2017 Jan-Mar;15(1):877. doi: 10.18549/PharmPract.2017.01.877. Epub 2017 Mar 15.
• Chen S, Pei YY, Zhang HW, Chen Y, Deng LC, Chen X, Wei ZG, Li D, Li ZH, Li RD, Liu ZR, Peng XC. Randomized, double-blind phase III trial of a dexamethasone-free regimen for managing highly emetogenic chemotherapy-induced nausea and vomiting. Int J Cancer. 2026 Jan 1;158(1):131-139. doi: 10.1002/ijc.70069. Epub 2025 Jul 30.

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Indications