Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

Overview

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.

Full Title of Study: “Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Interventions

  • Drug: alpha-lipoic acids
    • 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

Arms, Groups and Cohorts

  • Active Comparator: Low dose group
    • Patients who will receive 600 mg/day alpha-lipoic acid
  • Active Comparator: High dose group
    • Patients who will receive 1,200 mg/day alpha-lipoic acid

Clinical Trial Outcome Measures

Primary Measures

  • Increment of radioactive iodine uptake
    • Time Frame: 3months after alpha-lipoic acid treatment

Participating in This Clinical Trial

Inclusion Criteria

1. aged 20 to 75 years 2. under birth control, if fertile women 3. 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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won Bae Kim, Professor – Asan Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.