NCT03908528已完成不适用
Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- MDA
研究概览
简要总结
• Investigate the ability of alpha lipoic acid to counter act anthracycline associated cardiotoxicity and cumulative taxens-related PN in patients with breast cancer.
详细描述
Fifty breast cancer patients with stage from stage I to stage III will be involved in this study. Staging is done according to the American joint committee on cancer: TNM staging of breast cancer.
- All participants will be recruited from Tanta Oncology Center. The study will be approved by Research Ethics Committee of Damanhour University. All participants will give their consent.
- All 64 patients will be scheduled to receive 4 cycles of AC: cycled every 21 days followed by weekly cycle of taxol for 12 weeks.
Patients will be classified as follow:
- Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus placebo.
- Group two: 32 patients will receive the same regimen as group 1 in addition to oral 600 mg alpha lipoic acid (ALA) once daily.
All patients will be submitted to:
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients age ≥ 18 and < 70 years old with confirmed stage from stage I to stage III.
- •No evidence of metastases at initial assessment.
- •Patients has to have a good performance status (ECOG 0-2) according to Eastern Cooperative Oncology Group (ECOG) score.
- •Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin level ≥ 10g/dL).
- •Patients with adequate liver function (serum creatinine < 1.5 mg/dL) and adequate renal function (serum creatinine < 1.5 mg/dL, creatinine clearance (CrCl) > 45 ml/min).
- •Either pre operative or post operative chemotherapy are allowed.
排除标准
- •Evidence of metastases at initial assessment.
- •Pregnancy or breast-feeding patients.
- •Prior exposure to neurotoxic chemotherapy was not allowed (no carboplatin, vincristine, vinblastine, paclitaxel, or docetaxol ) for 6 months prior study treatment.
- •Clinical evidence of serious cardiac illness (myocardial dysfunctional, angina pectoris requiring anti-angina medication, poorly controlled hypertension, and uncontrolled arrhythmias).
- •Patients with a reduced cardiac output with a left ventricular ejection fraction (LVEF) ejection fraction < 50%.
- •Patients who had evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes).
- •Patients with a history of allergy to alpha-lipoic acid.
- •Concomitant use of multivitamins (vitamin E), opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication modifying agents (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are not allowed
结局指标
主要结局
MDA
时间窗: six months
Malondialdehyde
Neurotoxicity assessment
时间窗: six months
Neurotensin level
Cardiotoxcity assessment
时间窗: six months
serum Brain Natriuretic Peptide (BNP) level
oxidative stress and inflammatory markers
时间窗: six months
TNF-alpha level
次要结局
未报告次要终点
研究者
Rehab Werida
Lecturer
Damanhour University
研究点 (1)
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