Trial Outcomes & Findings for Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer (NCT NCT00251316)

NCT ID: NCT00251316

Last Updated: 2013-02-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2013-02-04

Participant Flow

87 patients were screened for the eligibility for this study. Total of 34 patients were enrolled into the study

The sample size for the trial is 100 patients and the goal for the number of patients to be randomized by November 2010 is 74 patients.

Participant milestones

Measure	Lithium Carbonate 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.	Placebo 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).
Overall Study STARTED	17	17
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Lithium Carbonate 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.	Placebo 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).
Overall Study Physician Decision	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lithium Carbonate n=15 Participants 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.	Placebo n=14 Participants 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).	Total n=29 Participants Total of all reporting groups
Age Continuous	39.8 years STANDARD_DEVIATION 11.8 • n=5 Participants	38.6 years STANDARD_DEVIATION 10.2 • n=7 Participants	39.2 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Placebo n=14 Participants 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).	Lithium Carbonate n=15 Participants 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.
The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.	10 Participants	10 Participants

Adverse Events

Lithium Carbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lithium Carbonate n=15 participants at risk 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.	Placebo n=15 participants at risk；n=14 participants at risk 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).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress	0.00% 0/15	7.1% 1/14 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Monica Skarulis

NIDDK, NIH

Phone: 301-496-6087

Email: monicas@intra.niddk.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place