Thyroid papilare cancer MedDRA version: 21.1 Level: PT Classification code 10066474 Term: Thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLUCOPHAGE 500mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Medical University of Bialystok
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subjects in reproductive age >18 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to metformin 2. Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure) 3. Subjects who take metformin during last week 4. Subjects with liver malfunction and abnormal liver tests results (ALT and AST activity >3ULN 5. Subjects with eGFR below 45 ml/min/1.73m2 6. Subjects with lactic acidosis or who have history of metabolic acidosis 7. Subjects with serum AMH concentration below lower range norm 8. Subjects with history of congestive heart disease NYHA stage III/IV 9. Subjects with acute myocardial ischemia (CCS 3-4) 10. Subjects with history of sepsis or severe infection 11. Subjects with lung disease (uncontrolled Asthma based on GINA 2000 Guidelines and COPD GOLD=3 stage) 12. Positive result of pregnancy test or planned pregnancy during the study 13. Alcohol dependent syndrome 14. BMI <18.5 kg/m2 15. Accompanying diseases with poor prognosis in the opinion of the researcher 16. As per the Investigator (or his designee) judgment, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason) 17. Unreliability or lack of cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives •To evaluate the efficacy of metformin on female fertility who were subjected to 131l treatment – ovarian reserve markers which are shown as AMH, inhibin B and FSH level in serum and antral follicle count checked by ultrasound.;Secondary Objective: Safety Objectives •Incidence of adverse events (AEs) and serious adverse events (SAEs) and changes in laboratory measurements Exploratory objectives •Patient reported outcome (PRO) for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-THY34) •Medical Resource Utilization (MRU) ;Primary end point(s): •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 in ultrasonography, between the study groups in women with papillary thyroid cancer treated with 131I, between the randomized visit and V3, V4, V5 and V6 visit;Timepoint(s) of evaluation of this end point: On a visit of 2 – m3, a visit of 3 – m6 and a visit of 4 -m9 and one year after administration of I131. The first interim analysis will be performed when 15% of the participants have completed the annual observation period according to the protocol. The second interim analysis will be performed when 45% of the participants have completed the one-year observation period according to the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate the effect of metformin on the difference in serum concentration of selected parameters of oxidative stress between the study groups in women with papillary thyroid cancer treated with 131I between the randomized visit and V3, V4, V5 and V6 visit • 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 between the randomized visit and V3, V4, V5 and V6 visit • 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 • Assessment of the quality of life using the QLQ-THY34 questionnaire dedicated to patients with thyroid cancer • Characteristics and tolerability of standard metformin dosage in patient with papillary thyroid cancer • Frequency of AEs requiring discontinuation of study drug or dose reduction • Change in basic laboratory assessment between visits ;Timepoint(s) of evaluation of this end point: On a visit of 2 – m3, a visit of 3 – m6 and a visit of 4 -m9 and one year after administration of I131. The first interim analysis will be performed when 15% of the participants have completed the one-year observation period according to the protocol. The second interim analysis will be conducted when 45% of the participants have completed the annual observation period according to the protocol. | — |
Countries
Poland
Contacts
Public ContactNational coordinator
Medical University of Bialystok/Professor Agnieszka Adamska MD.PhD
Outcome results
None listed