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Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer (RALT)

A

Asan Medical Center

Status and phase

Withdrawn
Phase 2

Conditions

Thyroid
Cancer

Treatments

Drug: alpha-lipoic acids

Study type

Interventional

Funder types

Other

Identifiers

NCT01396733
AMC_THY_001

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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