Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake

Conditions
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Thyroid, Cancer

Intervention / Treatment
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* Drug: alpha-lipoic acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 to 75 years under birth control, if fertile women Groups 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose group<br>Patients who will receive 600 mg/day alpha-lipoic acid | Drug: alpha-lipoic acids<br>* alpha-lipoic acid 600 mg/day or 1,200 mg/day 600 mg/day - Three tablets (200mg x 3), one time per day for 3 months 1,200 mg/day - Three tablets (200mg x 3), two times per day for 3 months<br>|
| Active Comparator: High dose group<br>Patients who will receive 1,200 mg/day alpha-lipoic acid | Drug: alpha-lipoic acids<br>* alpha-lipoic acid 600 mg/day or 1,200 mg/day 600 mg/day - Three tablets (200mg x 3), one time per day for 3 months 1,200 mg/day - Three tablets (200mg x 3), two times per day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increment of radioactive iodine uptake |  | 3months after alpha-lipoic acid treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid, cancer, redifferentiation, lipoic acid