Metformin hydrochloride for Papillary thyroid carcinoma

Inclusion criteria

• {"criterion_text":"- Female subjects in reproductive age >18 <45."}
• {"criterion_text":"- Subjects with diagnosed papillary thyroid carcinoma with various pathological stage TNM (I-II)."}
• {"criterion_text":"- Subjects not treated with 131I."}
• {"criterion_text":"- Willingness to comply with protocol procedures."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to metformin."}
• {"criterion_text":"- Subjects with history of sepsis or severe infection."}
• {"criterion_text":"- Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage)."}
• {"criterion_text":"- Positive result of pregnancy test or pregnancy planned during the study."}
• {"criterion_text":"- Alcohol or other substance dependent syndromes."}
• {"criterion_text":"- BMI <18.5 kg/m2."}
• {"criterion_text":"- Accompanying diseases with poor prognosis in the opinion of the researcher."}
• {"criterion_text":"- As per Investigator (or his designee) judgement, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason)."}
• {"criterion_text":"- Unreliability or lack of cooperation."}
• {"criterion_text":"- Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure)."}
• {"criterion_text":"- Subjects taking metformin during last week."}
• {"criterion_text":"- Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity >3ULN."}
• {"criterion_text":"- Subjects with eGFR below 45ml/min/1.73m2."}
• {"criterion_text":"- Subjects with lactic acidosis or having history of metabolic acidosis."}
• {"criterion_text":"- Subjects with serum AMH concentration below lower range norm."}
• {"criterion_text":"- Subjects with history of congestive heart disease NYHA stage III/IV."}
• {"criterion_text":"- Subjects with acute myocardial ischemia (CCS 3-4)."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be to evaluate the effect of metformin on the difference in serum AMH, inhibin B and FSH concentration and the number of antral follicles, assessed in the study groups consisted of the women with papillary thyroid cancer, treated with 131I, comparing received results during the randomized, V3, V4, V5 and V6 visits.","definition_or_measurement_approach":"Comparison of serum concentrations of AMH, inhibin B and FSH and ultrasound-assessed antral follicle count between randomized visit and visits V3, V4, V5 and V6."}

Secondary endpoints

• {"endpoint_text":"- To evaluate the metformin modulating impact on the concentrations of selected parameters of oxidative stress assessed in the study groups consisted of the women with papillary thyroid cancer, treated with 131I, comparing received results during the randomized, V3, V4, V5 and V6 visits.","definition_or_measurement_approach":"Assessment of selected oxidative stress parameters in serum/plasma compared between randomized visit and visits V3-V6."}
• {"endpoint_text":"- To evaluate the effect of metformin on the difference in serum concentration of selected parameters of apoptosis between the study groups in women with papillary thyroid cancer, treated with 131I, comparing received results during the randomized, V3, V4, V5 and V6 visits","definition_or_measurement_approach":"Measurement of selected apoptosis-related serum markers and comparison across visits (randomized, V3-V6)."}
• {"endpoint_text":"- To evaluate the effect of metformin on the difference of expression in selected microRNA between the study groups in women with papillary thyroid cancer, treated with 131I, between the randomized visit and V3, V4, V5 and V6 visit","definition_or_measurement_approach":"Measurement of expression levels of selected microRNA and comparison between randomized visit and V3-V6 visits."}
• {"endpoint_text":"- Assessment of the quality of life using the QLQ-THY34 questionnaire dedicated to patients with thyroid cancer.","definition_or_measurement_approach":"Patient-reported quality of life measured using the EORTC QLQ-THY34 questionnaire."}
• {"endpoint_text":"- Characteristics and tolerability of standard metformin dosage in patient with papillary thyroid cancer.","definition_or_measurement_approach":"Assessment of tolerability and characterisation of standard metformin dosing via adverse event reporting and clinical assessment."}
• {"endpoint_text":"- Frequency of AEs requiring discontinuation of study drug or dose reduction.","definition_or_measurement_approach":"Counting and reporting of adverse events leading to discontinuation or dose reduction of study drug."}
• {"endpoint_text":"- Change in basic laboratory assessment between visits.","definition_or_measurement_approach":"Comparison of laboratory test results across study visits."}

Poland

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

263

Number Of Sites

4

Number Of Participants

160

Primary sponsor

Full Name

Medical University Of Bialystok

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"sponsorDuties codes: [1,10,11,3,6,7,8,9]","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"external packaging, importation of investigational medicinal products (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}