Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients
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
研究组 & 干预措施
Chemotherapy plus Placebo for six Months
• Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus Placebo.
干预措施: Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) (Other)
Chemotherapy plus alpha lipoic acid for six Months
• Group two: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks in addition to oral 600 mg alpha lipoic acid (ALA) once daily.
干预措施: Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) (Dietary Supplement)
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