Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

Phase 2

Withdrawn

• Conditions: Thyroid; Cancer
• Interventions: Drug: alpha-lipoic acids

• Registration Number: NCT01396733
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose group	alpha-lipoic acids	Patients who will receive 1,200 mg/day alpha-lipoic acid
Low dose group	alpha-lipoic acids	Patients who will receive 600 mg/day alpha-lipoic acid

Primary Outcome Measures

Name	Time	Method
Increment of radioactive iodine uptake	3months after alpha-lipoic acid treatment

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of