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

This study is currently recruiting participants.
Verified July 2011 by Asan Medical Center
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01396733
First received: July 18, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Thyroid
Cancer
 Drug: alpha-lipoic acids
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Increment of radioactive iodine uptake [ Time Frame: 3months after alpha-lipoic acid treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose group
Patients who will receive 600 mg/day alpha-lipoic acid
 Drug: 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
Active Comparator: High dose group
Patients who will receive 1,200 mg/day alpha-lipoic acid
 Drug: 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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396733

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Tae Yong Kim, MD, PhD     82-2-3010-3249     tykim@amc.seoul.kr    
Principal Investigator: Won Bae Kim, MD, PhD            
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Won Bae Kim/professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01396733     History of Changes
Other Study ID Numbers: AMC_THY_001
Study First Received: July 18, 2011
Last Updated: July 18, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
thyroid
cancer
redifferentiation
lipoic acid

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thioctic Acid
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013