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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement combination of myo-inositol and selenium can prevent thyroid nodules with uncertain biopsy results (classified as TIR3a) from progressing toward cancer, potentially avoiding unnecessary surgery. **You may be eligible if...** - You are over 18 years old - You have thyroid nodules that came back as "indeterminate" on a fine needle aspiration biopsy (classified as TIR3a) - Adequate biopsy material is available for additional testing (Ki-67 and PCNA staining) - You have given written consent to participate **You may NOT be eligible if...** - You have been diagnosed with thyroid cancer or a different type of thyroid nodule - Your thyroid-stimulating hormone (TSH) is abnormal and requires thyroid hormone treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06736015


Related Trials