Evaluation of Metformin Effect on the Fertility of Women Treated With 131I for Thyroid Cancer

NCT05468554 | Not Yet Recruiting Phase 3

• 1 other identifier: 2020/ABM/01/00100
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in AMH, Inhibin B and FSH levels due to the action of metformin

  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

  4 years

Secondary Outcomes (3)

• Assessment of the effect of metformin on the parameters of oxidative stress

  4 years

• The evaluate of difference in serum concentration of selected parameters of apoptosis

  4 years

• The evaluate of difference in expression in selected microRNA

  4 years

Study Arms (3)

Metformin

EXPERIMENTAL

patients qualified to receive metformin and 131I treatment

Drug: metformin; Radiation: Radioactive iodine (I-131)

Placebo

ACTIVE COMPARATOR

patients receiving placebo and 131 I treatment

Radiation: Radioactive iodine (I-131)

Observational

NO INTERVENTION

observation group, patients after thyroidectomy, characterized by low risk of cancer progression, in this case, not qualified for 131I treatment

Interventions

metformin DRUG

Metformin will be used 3 times a day (3x500mg), starting in the first week with 1x1 tablet (1x500 mg for breakfast), in the second week, 2x1 tablet (500 mg for breakfast and 500 mg for dinner), from the 3rd week 3x1 tablet. (3x500mg with main meals). A gradual escalation of the dose is planned to the point of developing drug intolerance or toxicity that is unacceptable to the patient.

Metformin

Radioactive iodine (I-131) RADIATION

Patients qualified to receive 131I treatment

Metformin; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects in reproductive age \>18 \<45.
• Subjects with diagnosed papillary thyroid carcinoma with various pathological, stage TNM (I-II).
• Subjects not treated with 131I.
• Serum TSH concentration 0.1-4.9 mU/l.
• Willingness to comply with protocol procedures.

You may not qualify if:

• Hypersensitivity to metformin.
• Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure).
• Subjects taking metformin during last week.
• Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity \>3ULN.
• Subjects with eGFR below 45ml/min/1.73m2.
• Subjects with lactic acidosis or having history of metabolic acidosis.
• Subjects with serum AMH concentration below lower range norm.
• Subjects with history of congestive heart disease NYHA stage III/IV.
• Subjects with acute myocardial ischemia (CCS 3-4).
• Subjects with history of sepsis or severe infection.
• Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage).
• Positive result of pregnancy test or pregnancy planned during the study.
• Alcohol or other substance dependent syndromes.
• BMI \<18.5 kg/m2.
• Accompanying diseases with poor prognosis in the opinion of the researcher.

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Department of Endocrinology, Diabetology and Internal Medicine, Medical Univeristy of Bialystok

Bialystok, 15-276, Poland

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Metformin; Iodine-131

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Agnieszka Adamska, Assoc.Prof.

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Adamska, Assoc.Prof.

CONTACT

+48 85 746 86 07; methyr@umb.edu.pl, agnieszka.adamska@umb.edu.pl

Aldona Kowalska, Assoc.Prof.

CONTACT

+48 41 36 74 181; aldona.kowalska@onkol.kielce.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind / placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm A - patients qualified to receive metformin and 131I treatment, arm B - patients receiving placebo and 131 I treatment. Arm C- observation group, patients undergoing thyroidectomy, characterized by low risk of disease progression, in this case, not qualified for the 131I treatment.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 21, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 19, 2022

Record last verified: 2022-07

Locations

PL (1)