Actively Recruiting
Use of Myo-inositol and Selenium in Patients with Indeterminate Thyroid Nodules (TIR3A)
Led by Regina Elena Cancer Institute · Updated on 2024-12-16
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of myo-inositol and selenium supplements on thyroid nodules classified as TIR3A, a type of indeterminate thyroid nodule with a low risk of cancer (below 10%). The study aims to evaluate whether this supplement can reduce nodule size and stiffness, as well as affect cellular proliferation, compared to untreated patients. This pilot study is designed to assess both the safety and effectiveness of this treatment approach. Participants are randomly assigned to one of two groups: one group takes a daily tablet containing 600 mg of myo-inositol and 83 mcg of selenium for six months, while the other group receives no intervention. The study monitors changes in nodule characteristics using ultrasound and elastosonography, along with immunocytochemical analysis of proliferation markers. During the study, participants undergo regular clinical and ultrasound evaluations to measure nodule size, elasticity, thyroid hormone levels, and antibody levels. Researchers will compare these factors between treated and untreated groups after six months. The study also includes assessments of thyroid function and immune markers, with the overall participation period lasting six months.
CONDITIONS
Brief Title
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Both sexes
- Patients with thyroid nodules classified as TIR 3A based on cytological evaluation from the first fine needle aspiration
- Written informed consent provided
- Patients with appropriate samples available for immunocytochemical analysis of Ki-67 and PCNA
You will not qualify if you...
- Patients with thyroid malignancies diagnosed by cytology other than TIR3A
- Patients with abnormal thyroid stimulating hormone (TSH) levels requiring L-Thyroxine treatment
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take a daily oral supplement of Myo-Inositol 600 mg and Selenium 83 mcg or receive no intervention for 6 months.
Regular visits during the 6 months of supplementation
Duration - Follow-up after 6 months of treatment
Participants are monitored to evaluate changes in thyroid nodule characteristics and thyroid function after treatment.
Visits to assess thyroid nodule size, elasticity, and hormone levels after treatment completion
Trial Site Locations
Total: 1 location
1
Regina Elena National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
M
Marialuisa Appetecchia, MD
G
Giulia Puliani, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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