Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Increment of radioactive iodine uptake
研究概览
简要总结
Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or metastatic of DTC with defective I-131 uptake.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20 to 75 years
- •under birth control, if fertile women
- •who received radioactive iodine treatment for recurrent and metastatic thyroid cancer, and did not showed any uptake at post-therapeutic whole body scan
- •who planned to receive empirical radioactive treatment due to high expected recurrence
排除标准
- •allergic to alpha-lipoic acid
- •severe heart failure, lung disease, or end-stage renal disease
- •liver function abnormalities (x2.5 above normal limits)
- •neuropsychologically unstable patients
- •previous history of drug medication such as oral steroid, digoxin, theophylline, carbamazepine, valproic acid, phenobarbital, methotrexate, cyclosporin, tacrolimus within 3 months before this recruitment.
- •who is already taking alpha-lipoic acid for other purpose.
研究组 & 干预措施
Low dose group
Patients who will receive 600 mg/day alpha-lipoic acid
干预措施: alpha-lipoic acids (Drug)
High dose group
Patients who will receive 1,200 mg/day alpha-lipoic acid
干预措施: alpha-lipoic acids (Drug)
结局指标
主要结局
Increment of radioactive iodine uptake
时间窗: 3months after alpha-lipoic acid treatment
次要结局
未报告次要终点
研究者
Won Bae Kim
Professor
Asan Medical Center