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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


Phase 2
20 Years
75 Years
Open (Enrolling)
Both
Thyroid, Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increment of radioactive iodine uptake

Outcome Time Frame:

3months after alpha-lipoic acid treatment

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC_THY_001

NCT ID:

NCT01396733

Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Thyroid
  • Cancer
  • thyroid
  • cancer
  • redifferentiation
  • lipoic acid
  • Thyroid Neoplasms
  • Thyroid Diseases

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