Pentoxifylline Prophylactic Role Against Paclitaxel Chemotherapy-induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.
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
- None
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
- 否
入选标准
- •Adult patients> 18 years old.
- •Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
- •Adequate liver and kidney function.
排除标准
- •Children less than 18 years old.
- •Evidence of physical diseases or major surgery.
- •Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
- •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 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
PTX group
paclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks.
干预措施: Pentoxifylline (Drug)
Control group
include those assigned for Taxol-based chemotherapy without intervention for 12 weeks
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
时间窗: 12 weeks
次要结局
- Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)(12 weeks)
研究者
Hasnaa Osama
Lecturer of clinical pharmacy
Beni-Suef University