Experimental study for the evaluation of the effect of radioactive iodine therapy on free thyroxine circulating levels after oral administration of sodium levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer

Phase 1

Conditions: patients thyroidectomized for differentiated thyroid cancer
MedDRA version: 16.1Level: LLTClassification code 10057242Term: Post surgical hypothyroidismSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-000574-19-IT

Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

-Adult patients thyroidectomized for differentiated thyroid cancer
-Written informed consent to partecipate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Patients who will undergo radioactive iodine therapy in a hypothyroid state
-Inflammatory bowel diseases
-Malabsorption, chronic gastritis
-Treatment with estrogens, selective estrogen receptor modulators, drugs known to modify Levo-thyroxine absorption (i.e.: proton pump inhibitors, resins, iron, sucralfate, calcium, alluminum, chemotherapy, immunosuppressive therapy)
-Previous radiotherapy or radioactive iodine therapy
-Pregnancy
-Organ failure or other disease known to limit life expectancy
-History of chronic inflammatory/infectious/autoimmune diseases
-Any abnormality found during clinical examination at the screening visit, which according to the opinion of the investigator may be harmful for the patient in order to complete the study
-History of low compliance or psychiatric illness or any other condition which make the study inappropriate