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Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01396733
Acronym
RALT
Enrollment
0
Registered
2011-07-19
Start date
2011-04-30
Completion date
2013-12-31
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Thyroid

Keywords

thyroid, cancer, redifferentiation, lipoic acid

Brief 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.

Interventions

DRUGalpha-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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Increment of radioactive iodine uptake3months after alpha-lipoic acid treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026