Evaluating the Effect of Curcumin in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
研究概览
简要总结
Paclitaxel induced peripheral neuropathy is the most common and serious side effect associated with Paclitaxel treatment in breast cancer patients receiving Paclitaxel.
The efficacy of antioxidant molecules as neuroprotective strategies to preventing the development of peripheral neuropathy has been investigated in preclinical and clinical studies. Vitamin E and Glutathione have been explored as adjuvant therapies to preventing taxane-induced peripheral neuropathy. Other tested neuroprotective treatments with limited success include amifostine, glutamine and acetyl l-carnitine. Curcumin's antioxidant capacity is similar to other potent antioxidants, such as trolox (a vitamin E analog). Curcumin inhibits lipid peroxidation in different tissues, regulates intracellular levels of antioxidant enzymes (e.g., catalase, glutathione peroxidase and superoxide dismutase) and is an effective intracellular reactive oxygen species (ROS) scavenger.
The investigators are going to investigate the neuroprotective effect of Curcumin against Paclitaxel induced peripheral neuropathy.
详细描述
The work is a prospective, randomized, open label controlled study. A total of 90 breast cancer female patients will be enrolled in the study. Eligible patients will simply be randomized using random allocation generator, after the end of anthracycline adjuvant therapy to one of two groups, Group I: will receive paclitaxel regimen plus 2g of curcumin Group II: will receive paclitaxel regimen only.
The cases involved in the study will be recruited from Ain Shams Teaching Hospital.
All patients presenting to the department were assessed for eligibility according to certain inclusion and exclusion criteria.
Details of the research steps that the subscriber will be exposed to:
- Base line evaluation then alignment in either intervention or control group either for taking the interventional drug or standard of care in control group.
- Blood samples will be collected at baseline.
- Patient will be given a weekly supply of the medication and will be asked to take his prescribed dose daily.
- Every week all patients will be asked about their symptoms and if they experience any adverse drug reaction.
- Patients will receive the interventional drug until the last paclitaxel dose will be taken.
- After 3 months, another full clinical examination and blood sample will be obtained.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of early stage breast cancer with age > 18 years.
- •Performance status of the patients based on Eastern Cooperative Oncology Group (ECOG) from 0 to
- •Patients must receive paclitaxel 80 mg/m2 weekly or 175 mg/m2 every 3 weeks for 12 weeks.
- •Patients clinical parameters should be (ANC ≥ 1500/mm3). Platelet count 100,000/mm3) (serum total bilirubin < 1.5 mg/dl) and (creatinine < 1.5 mg/dl).
排除标准
- •Patients they had any signs and symptoms of clinical neuropathy.
- •Diabetes mellitus
- •Patients receiving vitamin supplementation including vitamin B1, B6 and B12
- •Patients receiving antidepressants, anticoagulants, opioids or anticonvulsants
- •Patients had a hypersensitivity to curcumin.
研究组 & 干预措施
Experimental group
Patients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy.
干预措施: Curcumin (Dietary Supplement)
Experimental group
Patients will receive their Paclitaxel-based chemotherapy along with Curcumin at a dose of oral 2g daily till the end of chemotherapy.
干预措施: Paclitaxel (Drug)
Control group
Patients will receive their Paclitaxel-based chemotherapy only
干预措施: Curcumin (Dietary Supplement)
Control group
Patients will receive their Paclitaxel-based chemotherapy only
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Evaluate the effect of Curcumin on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
时间窗: Baseline
After each cycle, initial evaluation of response will be done guided by clinical examination and functional assessment and questionnaire.
Evaluate the effect of Curcumin on the damage of nerve fibers induced by paclitaxel.
时间窗: Baseline
Nerve growth factor level will be obtained at day 0 and at the end of the paclitaxel course
次要结局
- Evaluate the effect of adding curcumin to paclitaxel-based chemotherapy on response rate in neoadjuvant therapy.(baseline)