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临床试验/NCT05829967
NCT05829967尚未招募不适用

Chemotherapy Induced Peripheral Neuropathy (CIPN ) and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes at Assuit University Hospital

Assiut University0 个研究点目标入组 60 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Rae of recovery in patients with CIPN who receiving taxanes and platinum

研究概览

简要总结

Neuropathies are a major cause of moderate to severe impairments in cancer patients.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

详细描述

Neuropathies are a major cause of moderate to severe impairments in cancer patients .

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

There are six main substance groups that cause damage to neurons developing CIPN: platinum-based antineoplastic agents, vinca alkaloids, epothilones (ixabepilone), taxanes, proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide).

Platinum-based chemotherapeutics (oxaliplatin, cisplatin and carboplatin) have the highest prevalence rates of CIPN, affecting ~ 70% of patients, often complicated by coasting Acute oxaliplatin-induced peripheral neuropathy (OIPN) can result in prolonged infusion times (~ 22%), dose reduction (15-43%) and treatment cessation (6-21.4%) Taxane-induced peripheral neuropathy (TIPN) (paclitaxel, Docitaxel and Cabazitaxel ) is the most common non-haematological adverse event of treatment,however, docetaxel is generally considered to be less neurotoxic than paclitaxel.

CIPN occurs in a dose-dependent manner usually ,duration of exposure, scheduling and combination therapies are also potential risk factors.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 and <75 .
  • Sex : Male or female
  • Adjuvant or metastatic
  • Receiving neurotoxic agents " platinum and taxanes "
  • No documentation of any other causes of neuropathy in their medical records as : congenital and DM

排除标准

  • Pt not receiving any neurotoxic CTH.
  • Detected other causes of neuropathy.

结局指标

主要结局

Rae of recovery in patients with CIPN who receiving taxanes and platinum

时间窗: Baseline

Possibility of recovery in patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens and assessment by nerve conduction test.

Number of patients with CIPN who receiving taxanes and platinum

时间窗: Baseline

Number of patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walaa Khalifa Fathy

Principal Investigator

Assiut University

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