Treatment for indeterminate thyroid nodules using myo-inositol and selenium
Use of Myo-inositol and Selenium in Patients with Indeterminate Thyroid Nodules (TIR3A)
This study is testing if a six-month treatment with a supplement of myo-inositol and selenium can help reduce the size and improve the elasticity of certain thyroid nodules in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06736015 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of indeterminate thyroid nodules classified as TIR3A. The study aims to determine if this treatment can reduce nodule size and cellular proliferation, assessed through ultrasound and immunocytochemistry. Participants will be randomly assigned to receive the supplement or standard care, with follow-up evaluations to assess changes in nodule characteristics. The trial is designed to provide insights into a potential non-invasive treatment option for patients with low-risk thyroid nodules.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with thyroid nodules classified as TIR3A based on cytological evaluation.
Not a fit: Patients with diagnosed thyroid malignancies or those requiring treatment for abnormal thyroid hormone levels will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option to reduce the size and risk of progression of indeterminate thyroid nodules.
How similar studies have performed: While there have been studies on myo-inositol and selenium for thyroid conditions, this specific approach for TIR3A nodules is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rome
- Regina Elena National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Marialuisa Appetecchia, MD — Regina Elena National Cancer Institute - IRCCS IFO
- Study coordinator: Marialuisa Appetecchia, MD
- Email: marialuisa.appetecchia@ifo.it
- Phone: 0039 0652666026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.