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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Marialuisa Appetecchia, MD
marialuisa.appetecchia@ifo.it
0039 0652666026
Backup
Giulia Puliani, MD, PhD
giulia.puliani@ifo.it
0039 065266034
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 30
Treatments
Experimental: Myo-inositol and selenium supplementation
Supplement with Myo-Inositol 600 mg + Selenium 83 mcg once a day for 6 months
No_intervention: Control
No intervention
Related Therapeutic Areas
Sponsors
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov