Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
研究概览
简要总结
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in 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
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Adult patients (>18 years old)
- •Early-stage breast cancer patients who will receive adjuvant paclitaxel
- •Performance status according to Eastern Cooperative oncology group (ECOG) <
- •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
- •Clinical neuropathy at prior to enrollment.
- •Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
- •Patients with a history of hypersensitivity to metformin.
- •Pregnant or lactating females.
- •Patients who are using metformin for any other cause.
- •Patients with Diabetes mellitus.
- •Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy.
- •Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
研究组 & 干预措施
Group II (control group)
who will receive adjuvant weekly paclitaxel.
干预措施: Placebo (Drug)
Group I (metformin group)
who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.
干预措施: Metformin (Drug)
结局指标
主要结局
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
时间窗: 8 weeks
Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)
次要结局
- the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale(8 weeks)
- Serum biomarkers level in (ng/mL)(8 weeks)
- Pain Severity(8 weeks)
- Time to develop grade 2or 3 PIPN(8 weeks)
研究者
Noha Mansour
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department
Mansoura University