A Study Combining Big Data Mining With Experimental and Clinical Research to Validate the Alleviating Effect of Fish Oil on Bortezomib-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Grading of Peripheral Neuropathy according to NCI-CTCAE criteria
研究概览
简要总结
The goal of this study is to find out if taking fish oil by mouth can help prevent or lessen a side effect called peripheral neuropathy in patients who are being treated with the chemotherapy drug bortezomib.
We are mainly looking to answer one question: Can fish oil reduce the chances of getting this nerve damage, or make it less severe, for these patients?
详细描述
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To understand the incidence of bortezomib-induced peripheral neuropathy (PN) and the resulting rates of treatment discontinuation and dose reduction, a real-world retrospective study will be conducted.
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Potential preventive drugs for bortezomib-induced PN will be identified by mining the FDA Adverse Event Reporting System (FAERS) database.
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The preventive effects of the candidate drugs against bortezomib-induced PN will be validated through in vivo and in vitro experiments.
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A prospective, randomized controlled trial will be performed to confirm the efficacy of the candidate drugs in preventing bortezomib-induced PN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Aged 18 years or older, regardless of gender. (2) Diagnosed with multiple myeloma (MM) according to the "Guidelines for the Diagnosis and Management of Multiple Myeloma," and scheduled to receive bortezomib as first-line therapy.
- •(3) Absence of baseline peripheral neuropathy prior to the initiation of bortezomib treatment.
- •(4) Provision of signed informed consent.
排除标准
- •(1) Patients with poor medication adherence. (2) Women who are pregnant or lactating. (3) Cases deemed ineligible by the investigator.
研究组 & 干预措施
Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish
干预措施: Fish Oil (Containing Omega-3 Acids) (Dietary Supplement)
结局指标
主要结局
Grading of Peripheral Neuropathy according to NCI-CTCAE criteria
时间窗: From enrollment to the end of treatment at 24 weeks
次要结局
未报告次要终点