"Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Relative reduction in tumor size after neoadjuvant chemotherapy treatment
研究概览
简要总结
Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult female patients >18 years old with histologic confirmation of invasive breast cancer
- •Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
- •Adequate hepatic, renal, and bone marrow functions
排除标准
- •Patients on treatment regimen of phosphodiesterase inhibitors
- •Patients who are taking antiplatelet or anticoagulant treatment
- •Patients who are allergic to phosphodiesterase inhibitors
- •History of recent hemorrhagic events
- •Active peptic ulcer
研究组 & 干预措施
Pentoxyphyllin group
Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients are prescribed 400 mg pentoxifylline tablets to be taken three times daily.
干预措施: Pentoxifylline Oral Tablet (Drug)
Control group
Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients will take placebo tablets three times daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Relative reduction in tumor size after neoadjuvant chemotherapy treatment
时间窗: 6 months
Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.
次要结局
- The number of patients achieving a pathological complete response(6 months)
- The relative change of left ventricular ejection fraction (LVEF)(3 months)
- The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5(2 months)
- The relative change of liver function tests(6 months)
- The change in Serum Creatinine concentration(6 months)
研究者
Omar Hamdy
Principal Investigator
Mansoura University