Evaluation of The Effect of N-AcetylCysteine in The Prevention of Paclitaxel-Induced Peripheral Neuropathy in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Incidence of chemotherapy induced-peripheral neuropathy
研究概览
简要总结
The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with paclitaxel on the clinical outcomes of patients with peripheral neuropathy, paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients.
new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has neuroprotective effect, the aim of the study is to evaluate the effect of N- acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral neuropathy.
详细描述
Paclitaxel is a first-line chemotherapeutic treatment of solid tumors. Neuronal damage also seems to have a major role in paclitaxel-induced neuropathic pain, paclitaxel contributes to ROS formation (superoxide, hydroxyl radical, nitric oxide and hydrogen peroxide) in neuronal mitochondria that are involved in nerve injury-induced.
N-acetylcysteine (NAC) is a cysteine pro-drug and glutathione (GSH) precursor which is a protective agent and detoxifies and scavenges reactive oxygen species (ROS), which seems to help normalize the oxidative status.
It has been reported that high dose of N-acetylcysteine shown to Prevent retrograde motor neuron death after neonatal peripheral nerve injury and significantly increases motor neuron survival, which may improve functional outcomes after obstetrical brachial plexus injury in rats.
Also, it has been reported that NAC significantly inhibited CCI-induced microglia activation but elicited no notable effects on astrocytes. These results demonstrate an effective and safe approach that has been used clinically to alleviate neuropathic pain via the powerful inhibition of the activation of MMPs in rats.
N-acetylcysteine has been shown to have neuroprotective effects against oxaliplatin-based adjuvant chemotherapy in colon cancer patients with Oral administration of N-acetylcysteine1,200 mg) was given one and a half hours before each oxaliplatin administration.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old).
- •Breast cancer patients who will receive adjuvant weekly paclitaxel for 12 cycles.
- •ECOG performance status 0-2
- •Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine <1.5 mg/dl).
排除标准
- •Patients who have any of the following:
- •Clinical neuropathy.
- •Diabetes mellitus.
- •Patients receiving vitamin B1, B6, B12,or other vitamin supplemental therapy.
- •Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
- •Hypersensitivity to NAC.
研究组 & 干预措施
control
they will receive paclitaxel 80 mg/m2 once per week for 12 weeks only
干预措施: Paclitaxel (Drug)
high dose N-acetyl cysteine
they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and high dose N-acetylcysteine (1200 mg twice daily) for the paclitaxel treatment period
干预措施: high dose N-acetylcysteine (Dietary Supplement)
high dose N-acetyl cysteine
they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and high dose N-acetylcysteine (1200 mg twice daily) for the paclitaxel treatment period
干预措施: Paclitaxel (Drug)
low dose N-acetyl cysteine
they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and low dose N-acetylcysteine (600mg twice daily) for the paclitaxel treatment period.
干预措施: low dose N-acetylcysteine (Dietary Supplement)
low dose N-acetyl cysteine
they will receive paclitaxel 80 mg/m2 once per week for 12 weeks and low dose N-acetylcysteine (600mg twice daily) for the paclitaxel treatment period.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Incidence of chemotherapy induced-peripheral neuropathy
时间窗: up to 12 week
Number of patients reported neuropathy from paclitaxel
次要结局
- severity of chemotherapy induced-peripheral neuropathy(at baseline, at the end of 6 cycle and at the end of 12 cycles)
- Adverse effects(at baseline and each cycle up to 12 week)
研究者
Hadeer Gamal Khalefa
pharmacist
Nasser Institute For Research and Treatment