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NCT01396733 Clinical Trial

Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

Cancer Clinical Trial

— RALT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01396733
Other study ID # AMC_THY_001
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date April 2011
Est. completion date December 2013

Study information
Verified date July 2021
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increment of radioactive iodine uptake 3months after alpha-lipoic acid treatment
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