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Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer

Primary Purpose

Thyroid Cancer, Differentiated Thyroid Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid Neoplasm, I-131, Radiation Dose, Radiation Effect, Pharmaceutical Adjuvant, Thyroid Cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery Patients younger than 45 years with any size of primary papillary or follicular tumor Patients older than 45 years with: primary papillary tumor less than 4 cm or primary follicular tumor less than 1 cm EXCLUSION CRITERIA Patients with postsurgical thyroid remnant more than 5 g Patients with distant metastases Patients above 45 years of age having: known cervical lymph nodes metastases microscopic multifocal follicular cancer microscopic extraglandular invasion of follicular cancer gross extraglandular invasion of papillary or follicular cancer Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer. Pregnant or lactating women Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone Patients on chronic lithium therapy for psychiatric illness Patients with current unstable cardiovascular conditions Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lithium Carbonate

Placebo

Arm Description

Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.

Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).

Outcomes

Primary Outcome Measures

The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2005
Last Updated
January 29, 2013
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00251316
Brief Title
Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Official Title
The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will examine the safety and effectiveness of using lithium, which has been used to enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid. Participants are randomly assigned to receive lithium capsules or placebo (look-alike capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before starting treatment and are then admitted to the NIH Clinical Center for study and treatment for 11 days, during which they remain on the low-iodine diet. Blood samples are collected almost every day to analyze thyroid hormones, kidney and liver function, lithium concentrations and other tests.
Detailed Description
Postsurgical thyroid remnant ablation with (131)I is considered standard clinical care for most cases of papillary and follicular thyroid cancer, to eliminate normal thyroid tissue which may contain microscopic cancer. Furthermore, ablation enhances the sensitivity of subsequent (131)I scanning and serum thyroglobulin (TG) measurement for the detection of recurrent or persistent disease. Low dose (131)I (30 mCi) successfully ablates thyroid remnant in 8-61% of cases. This dose can be repeated and result in overall less radiation exposure than that associated with high dose therapy (100 mCi). Ablation achieved with one or more small doses of radioactive iodine is not associated with decreased survival or cancer recurrence. According to the literature there is no difference in the 30-year recurrence rates between groups receiving low and high dose ablation therapy for well differentiated thyroid cancer without distant metastases at the time of initial therapy. The benefits of using low dose of (131)I are minimization of whole body radiation exposure, reduction in side effects and lower cost. Higher rates of successful ablation by low dose of 131I could be achieved by increasing uptake of (131)I and/or lengthening retention of radioiodine in the remnant thyroid tissue. Recombinant human thyroid-stimulating hormone (rhTSH) has been used successfully to increase radioiodine uptake. Lithium has been used to increase radioiodine retention and has been shown to be useful in the treatment of residual or metastatic cancer. The combination of rhTSH and lithium as adjuncts to 30 mCi radioactive iodine (RAI) ablation therapy in low risk thyroid cancer patients may provide a method that reduces the cumulative dose of radioiodine needed to successfully treat thyroid cancer. The specific aim of this study is to determine whether adjunct lithium carbonate improves the success rate of postsurgical ablation of thyroid remnants using low dose (131)I (30 mCi) and rhTSH in low risk patients with differentiated thyroid carcinoma. Patients with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the National Thyroid Cancer Treatment Cooperative Study (NTCTCS) classification at time of surgery, will be enrolled. Eligible patients will have had a total or near-total thyroidectomy within 6 months of enrollment. This randomized, placebocontrolled, double-blind study will permit an evaluation of the risk/benefit ratio of adding lithium as an adjuvant to the already established method of administering low-dose (131)I ablation therapy, to optimize the (131)I retention. All patients will undergo diagnostic rhTSH (123)I whole body scan at the end of the study to assess the success of thyroid ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Differentiated Thyroid Carcinoma
Keywords
Thyroid Neoplasm, I-131, Radiation Dose, Radiation Effect, Pharmaceutical Adjuvant, Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium Carbonate
Arm Type
Experimental
Arm Description
Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Other Intervention Name(s)
Lithium carabonate
Intervention Description
30 mCi of 131I
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Identical placebo
Intervention Description
Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
Primary Outcome Measure Information:
Title
The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery Patients younger than 45 years with any size of primary papillary or follicular tumor Patients older than 45 years with: primary papillary tumor less than 4 cm or primary follicular tumor less than 1 cm EXCLUSION CRITERIA Patients with postsurgical thyroid remnant more than 5 g Patients with distant metastases Patients above 45 years of age having: known cervical lymph nodes metastases microscopic multifocal follicular cancer microscopic extraglandular invasion of follicular cancer gross extraglandular invasion of papillary or follicular cancer Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer. Pregnant or lactating women Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone Patients on chronic lithium therapy for psychiatric illness Patients with current unstable cardiovascular conditions Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica C Skarulis, M.D.
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12583960
Citation
Sherman SI. Thyroid carcinoma. Lancet. 2003 Feb 8;361(9356):501-11. doi: 10.1016/s0140-6736(03)12488-9.
Results Reference
background
PubMed Identifier
10365671
Citation
Mazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid. 1999 May;9(5):421-7. doi: 10.1089/thy.1999.9.421.
Results Reference
background
PubMed Identifier
7977430
Citation
Mazzaferri EL, Jhiang SM. Long-term impact of initial surgical and medical therapy on papillary and follicular thyroid cancer. Am J Med. 1994 Nov;97(5):418-28. doi: 10.1016/0002-9343(94)90321-2. Erratum In: Am J Med 1995 Feb;98(2):215.
Results Reference
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Links:
URL
http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2006-DK-0025.html
Description
NIH Clinical Center Detailed Web Page

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Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer

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