RecruitingNot ApplicableNCT06736015

Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)

Use of Myo-inositol and Selenium in Patients with Indeterminate Thyroid Nodules (TIR3A)


Sponsor

Regina Elena Cancer Institute

Enrollment

30 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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,
  • Patients with appropriate material for subsequent immunocytochemical analysis of Ki-67 and PCNA

Exclusion Criteria3

  • 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

Interventions

DIETARY_SUPPLEMENTMyo-Inositol 600 mg + Selenium 83 mcg

Myo-Inositol 600 mg + Selenium 83 mcg: 1 tablet once a day for 6 months


Locations(1)

Regina Elena National Cancer Institute

Rome, Italy

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NCT06736015


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