Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading
研究概览
简要总结
This clinical trial is a randomized clinical trial that aims to assess the usefulness of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of doxorubicin/cyclophosphamide fllowed by taxane for breast cancer patients to decrease the incidence of developing toxicities, and enhance the quality of patient life using the EQ-5D-3L questionnaire. The participant will administer Pentoxifylline oral tablets three times per day along with the treatment protocol, starting from the first doxorubicin/cyclophosphamide cycle till the end of the chemotherapy cycles. The researchers will compare the incidence and grade of mucosities, neuropathy, and other chemotherapy-related toxicities in the presence or absence of oral pentoxifylline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 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 a 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
- •patients who have mouth or teeth problem.
研究组 & 干预措施
Pentoxifylline group
The patient will take 400 mg tablets of Pentoxifylline, 3 tablets per day, starting from the first day of the first cycle of doxorubicin/cyclophosphamide till finishing the cycles of neoadjuvant chemotherapy comprised intravenous Doxorubicin 60 mg/m²/cycle with intravenous Cyclophosphamide 600 mg/m²/cycle for four cycles, followed by weekly paclitaxel, dose-dense paclitaxel or docetaxel.
干预措施: Pentoxifylline 400mg plus chemotherapy (Drug)
Control group
The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading
时间窗: 6 months
The number of patients reported grade 2 or more peripheral neuropathy in the two groups.
次要结局
- The incidence of grade 2 or more oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading(6 months)
- The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading(6 months)
- The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading(6 months)
- the incidence of gastrointestinal side effects including: abdominal discomfort, bloating, diarrhea, constipation will be assessed in the two groups using Common Terminology Criteria Adverse Event grading(6 months)
研究者
Omar Hamdy
Principal Investigator
Mansoura University