Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

NCT ID: NCT01396733

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose group

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

Group Type: ACTIVE_COMPARATOR

alpha-lipoic acids

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

alpha-lipoic acids

Intervention Type: 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

Interventions

alpha-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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Bae Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC_THY_001

Identifier Type: -

Identifier Source: org_study_id