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

NCT06736015 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Thyroid Nodule

Interventions

DIETARY_SUPPLEMENT

Myo-Inositol 600 mg + Selenium 83 mcg

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

Sponsors & Collaborators

  • Regina Elena Cancer Institute

    lead OTHER

Principal Investigators

  • Marialuisa Appetecchia, MD · Regina Elena National Cancer Institute - IRCCS IFO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2026-03-30
Completion
2026-10-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736015 on ClinicalTrials.gov