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WithdrawnNCT01396733RALTUpdated Jul 23, 2021

Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

A Phase 2 interventional study of alpha-lipoic acids in Thyroid and Cancer, sponsored by Asan Medical Center. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-23.

Sponsored by Asan Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Thyroid
  • Cancer

Keywords

  • thyroid
  • cancer
  • redifferentiation
  • lipoic acid
03

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

Browse Thyroid Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Low dose group

    Patients who will receive 600 mg/day alpha-lipoic acid

    Drug: alpha-lipoic acids

  • Active comparator
    High dose group

    Patients who will receive 1,200 mg/day alpha-lipoic acid

    Drug: alpha-lipoic acids

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

06

What researchers measure

Primary outcomes

  1. Increment of radioactive iodine uptake

    Time frame: 3months after alpha-lipoic acid treatment

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01396733
Lead sponsor
Asan Medical Center
Responsible party
Won Bae Kim (Professor, Asan Medical Center) — Principal investigator
First posted
Jul 19, 2011
Start date
Apr 2011
Primary completion
Dec 2012
Completion
Dec 2013
Last update
Jul 23, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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