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临床试验/NCT05189535
NCT05189535已完成2 期

"Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

Ain Shams University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年10月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Incidence of Paclitaxel induced-peripheral neuropathy

研究概览

简要总结

The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.

详细描述

Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.

Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

single blinded

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult patients (18-80 years old).
  • Female patients.
  • Pathologically proved breast cancer.
  • Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance ≤ 2
  • Adequate bone marrow function.
  • Adequate liver and kidney function.

排除标准

  • Patients with preexisting clinical neuropathy.
  • Patients with diabetes mellitus.
  • Metastatic breast cancer.
  • Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
  • Patients treated with medications that increase the risk of neuropathy.
  • Hypersensitivity to pentoxifylline or xanthine derivatives.
  • Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer.
  • Patients at high risk for bleeding or taking medications that increase risk of bleeding.

研究组 & 干预措施

pentoxifylline 400 mg

Experimental

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period.

干预措施: Pentoxifylline (Drug)

pentoxifylline 400 mg

Experimental

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period.

干预措施: Paclitaxel (Drug)

Placebo

Placebo Comparator

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period..

干预措施: Paclitaxel (Drug)

Placebo

Placebo Comparator

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period..

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of Paclitaxel induced-peripheral neuropathy

时间窗: 12 weeks

Number of patients reported neuropathy due to paclitaxel

次要结局

  • Grade of severity of Paclitaxel induced-peripheral neuropathy in patients who developed neuropathy(at baseline and on weekly bases for 12 weeks)
  • Evaluation of Safety and tolerability of pentoxifylline(evaluation on weekly bases for 12 weeks.)
  • The need for dose reduction or drug discontinuation in pentoxifylline and placebo arm.(12 weeks)

研究者

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

Sondos Sherif Ismail

Clinical Pharmacy, Ain Shams University

Ain Shams University

研究点 (1)

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