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

NCT06736015 | Recruiting

• 1 other identifier: RS39/IRE/23(2869)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TIR3A; indeterminate thyroid nodules; myo-inositol; selenium

Outcome Measures

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)

  6 months

Secondary Outcomes (6)

• Evaluation of the inibition of the growth of thyroid nodules with Myo-inositol and Selenium supplementation

  6 months

• Evaluation of the differences in thyroid nodules volume in patients treated with selenium and myo-inositol

  6 months

• Evaluation of the differences in thyroid hormones in patients treated with selenium and myo-inositol

  6 months

• Evaluation of the differences in anti-thyroid antibodies, in patients treated with selenium and myo-inositol

  6 months

• Evaluation of the differences in thyroglobulin in patients treated with selenium and myo-inositol

  6 months

Study Arms (2)

Myo-inositol and selenium supplementation

EXPERIMENTAL

Supplement with Myo-Inositol 600 mg + Selenium 83 mcg once a day for 6 months

Dietary Supplement: Myo-Inositol 600 mg + Selenium 83 mcg

Control

NO INTERVENTION

No intervention

Interventions

Myo-Inositol 600 mg + Selenium 83 mcg DIETARY_SUPPLEMENT

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

Also known as: Tiroxil 4.0

Myo-inositol and selenium supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Inositol; Selenium

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Marialuisa Appetecchia, MD

  Regina Elena National Cancer Institute - IRCCS IFO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialuisa Appetecchia, MD

CONTACT

0039 0652666026; marialuisa.appetecchia@ifo.it

Giulia Puliani, MD, PhD

CONTACT

0039 065266034; giulia.puliani@ifo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Oncological Endocrinology Unit

Model Details: One group will receive myo-inositol and selenium and one group will not be treated

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 16, 2024
• Study Start: October 23, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After study result publication
• Access Criteria: GARRbox user and working group

Locations

IT (1)