Back to resultsRedifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer (RALT)
Primary Purpose
Thyroid, Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
alpha-lipoic acids
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid focused on measuring thyroid, cancer, redifferentiation, lipoic acid
Eligibility Criteria
Inclusion Criteria:
- 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
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low dose group
High dose group
Arm Description
Patients who will receive 600 mg/day alpha-lipoic acid
Patients who will receive 1,200 mg/day alpha-lipoic acid
Outcomes
Primary Outcome Measures
Increment of radioactive iodine uptake
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01396733
Brief Title
Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer
Acronym
RALT
Official Title
Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Cancer
Keywords
thyroid, cancer, redifferentiation, lipoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose group
Arm Type
Active Comparator
Arm Description
Patients who will receive 600 mg/day alpha-lipoic acid
Arm Title
High dose group
Arm Type
Active Comparator
Arm Description
Patients who will receive 1,200 mg/day alpha-lipoic acid
Intervention Type
Drug
Intervention Name(s)
alpha-lipoic acids
Intervention Description
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
Primary Outcome Measure Information:
Title
Increment of radioactive iodine uptake
Time Frame
3months after alpha-lipoic acid treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer
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