CTRI/2026/02/104005尚未招募4 期
Efficacy of Prophylactic Dexamethasone in Preventing Opioid-Induced Nausea and Vomiting in Cancer Patients: A Randomized Controlled Trial
未提供1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年3月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Nausea severity score measured using a 0–10 Numerical Rating Scale
研究概览
简要总结
Opioid-induced nausea and vomiting (OINV) remains a significant barrier to effective pain control in cancer patients. Despite the availability of antiemetics, prophylactic use is not routinely practiced for morphine-induced nausea. This trial evaluates the efficacy of oral dexamethasone in reducing OINV in opioid-naïve adult cancer patients. If proven effective, dexamethasone could become a simple, cost-effective, and scalable intervention in supportive oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than 18 years
- •Diagnosed cancer (any histology)
- •Opioid-naïve, planned for oral morphine
- •Expected to take oral morphine for at least 5 days
- •Able to understand symptom reporting and provide consent.
排除标准
- •Current or recent corticosteroid therapy
- •Concurrent antiemetics initiated prophylactically
- •History of steroid allergy or contraindication
- •Cognitive impairment or inability to communicate
- •Uncontrolled diabetes mellitus 6.
结局指标
主要结局
Nausea severity score measured using a 0–10 Numerical Rating Scale
时间窗: Day 1, Day 3, and Day 5 after initiation of oral morphine
次要结局
- Number of vomiting episodes Rescue antiemetic use(Emergency visits due to opioid-induced nausea & vomiting.)
研究者
Seema Mishra
AIIMS, New Delhi
研究点 (1)
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