Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

NCT01396733 | Withdrawn Phase 2 DMC

• 1 other identifier: AMC_THY_001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid; Cancer

Keywords

thyroid; cancer; redifferentiation; lipoic acid

Outcome Measures

Primary Outcomes (1)

• Increment of radioactive iodine uptake

  3months after alpha-lipoic acid treatment

Study Arms (2)

Low dose group

ACTIVE COMPARATOR

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

Drug: alpha-lipoic acids

High dose group

ACTIVE COMPARATOR

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

Drug: alpha-lipoic acids

Interventions

alpha-lipoic acids DRUG

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

High dose group; Low dose group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 20 to 75 years
• under birth control, if fertile women
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Thyroid Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

KR (1)