Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
ConditionThyroid Nodule
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute
About this trial
Thyroid nodules present a variable risk of malignancy depending on the cytological result obtained from the ultrasound-assisted thyroid fine needle aspiration biopsy. According to the Italian Cytology classification SIAPEC-IAP 2014, the TIR3A nodules are indeterminate nodules with a risk of malignancy lower than 10%. Clinical and instrumental follow-up is recommended in these cases, including repetition of the fine needle aspiration.
A study have demonstrate the effect of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of benign thyroid nodules.
Our hypothesis is that the use of this supplement can determine a reduction in the size and consistency of the nodule assessed through ultrasound and elastosonography also in cytologically indeterminate (TIR3A) nodules and that treatment can reduce the cellular proliferation of these nodules assessed by immunocytochemistry.
Therefore, we design a prospective randomized pilot study to assess efficacy and safety of myo-inositol and selenium in TIR3a thyroid nosules, comparing treated and untreated patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (>18 years old),
both sexes,
patients presenting thyroid nodules classified as TIR 3A, based on cytological evaluation on sample from the first fine needle aspiration (FNA),
written Informed consent,
Disqualifiers
Patients with diagnosed thyroid malignancies of cytological diagnosis other than TIR3A
pathological levels of the thyroid stimulating hormone (TSH) which required L-Thyroxine treatment starting
pregnancy and/or breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Myo-Inositol 600 mg + Selenium 83 mcg
Dietary supplementMyo-Inositol 600 mg + Selenium 83 mcg: 1 tablet once a day for 6 months
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Myo-inositol and selenium supplementationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Evaluation of differences in elastosonography after six months in patients treated with selenium and myo-inositol and patients not treated (controls)
Changes in elastosonographic score after treatment (comparing treated and untreated patients)- Score varies from 1 (soft) to 4 (hard)
Time frame
6 monthsSecondary outcomes
1
Evaluation of the inibition of the growth of thyroid nodules with Myo-inositol and Selenium supplementation
Changes in immunocytochemistry proliferation index (such as Ki-67 labeling index, from 0% to 100%) (comparing treated and untreated patients)
Time frame
6 months2
Evaluation of the differences in thyroid nodules volume in patients treated with selenium and myo-inositol
Changes in thyroid nodules volume (ml) in patients treated with selenium and myo-inositol (comparing treated and untreated patients)
Time frame
6 months3
Evaluation of the differences in thyroid hormones in patients treated with selenium and myo-inositol
Changes in thyroid hormones levels (TSH, FT3, FT4) in patients treated with selenium and myo-inositol (comparing treated and untreated patients)
Time frame
6 months4
Evaluation of the differences in anti-thyroid antibodies, in patients treated with selenium and myo-inositol
Changes in anti-thyroid antibodies (AbTg, AbTPO) in patients treated with selenium and myo-inositol (comparing treated and untreated patients)
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov