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临床试验/CTRI/2025/08/092535
CTRI/2025/08/092535尚未招募4 期

Effect of Olanzapine and Ondansetron for Prevention of Platinum based Chemotherapy-Induced Nausea and Vomiting: An Open Label, Randomized Controlled Study

G.Karthik1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
116
试验地点
1
主要终点
To compare the effect of olanzapine and ondansetron in prevention and control of Platinum based chemotherapy

研究概览

简要总结

Platinum-based chemotherapy is a cornerstone in the treatment of various malignancies but is often complicated by chemotherapy-induced nausea and vomiting (CINV). CINV can severely affect patients’ adherence to cancer therapy and diminish their quality of life, especially as conventional antiemetic regimens may not completely prevent these distressing symptoms. Both acute (within 24 hours) and delayed (after 24 hours) phases of nausea and vomiting present significant management challenges, particularly in patients receiving highly emetogenic agents like cisplatin.

Olanzapine, primarily an atypical antipsychotic, has gained attention for its potent antiemetic effects due to its blockade of multiple neurotransmitter receptors involved in nausea pathways—including dopaminergic, serotonergic, adrenergic, and histaminic receptors. Its broad pharmacological profile makes it a candidate for both acute and delayed CINV, either alone or as an adjunct to standard therapy. The drug’s use at a lower dose (5mg) is being actively explored, aiming to maximize benefit while minimizing risk of sedation and other side effects.

This open-label, randomized controlled trial conducted at R.L. Jalappa Hospital and Research Centre enrolled 116 adult patients undergoing platinum-based chemotherapy. Participants were randomized to two groups: one received olanzapine in addition to standard antiemetics (dexamethasone and ondansetron), while the control group continued with standard antiemetics alone. Efficacy was measured using validated questionnaires to assess the presence and severity of nausea and vomiting in both the acute and delayed phases across 3–6 chemotherapy cycles. Adverse effects of the study drugs were systematically tracked using established causality and probability scales.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 75 years of either gender Patients receiving Platinum based chemotherapy regimen for cancer treatment Eastern Co-operative Oncology Group (ECOG) performance status.
  • 0/1 No prior/ current use of anti-psychotic medications No history of hypersensitivity to olanzapine or study drugs.

排除标准

  • Patients experiencing clinically significant nausea in 24 hours preceding the first dose Pregnant or lactating women.

结局指标

主要结局

To compare the effect of olanzapine and ondansetron in prevention and control of Platinum based chemotherapy

时间窗: Nausea and vomiting is assessed by Multinational Association of Supportive Care in Cancer Tool (MASCC) and Visual Analogue Scale (VAS) score at baseline, chemotherapy cycle 1,2,3,4,5,6

induced nausea and vomiting

时间窗: Nausea and vomiting is assessed by Multinational Association of Supportive Care in Cancer Tool (MASCC) and Visual Analogue Scale (VAS) score at baseline, chemotherapy cycle 1,2,3,4,5,6

次要结局

  • To assess the adverse effects of olanzapine & ondansetron using WHO causality assessment scale & Naranjo scale.(Adverse effects of drug & safety will be assessed by WHO causality assessment scale & Naranjo scale at baseline, chemotherapy cycle 1,2,3,4,5,6)

研究者

发起方
G.Karthik
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Karthik G

Sri Devaraj Urs Medical College

研究点 (1)

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