Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer
Conditions
Thyroid - Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
thyroid, cancer, redifferentiation, lipoic acid
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: alpha-lipoic acids
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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.
Location
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Tae Yong Kim, MD, PhD - 82-2-3010-3249 - tykim@amc.seoul.kr
Start Date
April 2011
Completion Date
December 2013
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page