Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Condition: Thyroid Cancer; Differentiated Thyroid Carcinoma
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Lithium Carbonate; Placebo
Intervention description: 30 mCi of 131I; 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 MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Thyroid Neoplasm; I-131; Radiation Dose; Radiation Effect; Pharmaceutical Adjuvant; Thyroid Cancer

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.
    

Eligibility criteria:

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