Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    77
  • sponsor
    Samsung Medical Center
Updated on 4 October 2021
Accepts healthy volunteers

Summary

The purpose of the study is to investigate the effects of metformin in addition to the conventional progestin therapy in the fertility-sparing treatment of early stage endometrial cancer.

Details
Condition Endometrial Cancer Stage I
Treatment Metformin
Clinical Study IdentifierNCT04792749
SponsorSamsung Medical Center
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Endometrial cancer radiologic International Federation of Obstetrics and Gynecology (FIGO) stage IA patients
Endometrioid endometrial cancer patients
FIGO cellular differentiation grade 1 patients
Patients who wish to preserve fertility
Patients who understand that the recommended treatment of endometrial cancer is surgical treatment even in early stages, but still wish to preserve fertility and avoid surgical treatment
Patients who have good performance status (Eastern Cooperation Oncology Group (ECOG) performance score equal to or greater than 3)
Patients who are not contraindicated to the progestin therapy
Patients who are not contraindicated to the use of metformin

Exclusion Criteria

Patients who have already received chemotherapeutic or radiotherapeutic treatments for endometrial cancer
Patients whose disease is already advanced and not indicated for fertility-sparing treatment
Patients whose tumor cellular differentiation grade is greater than FIGO grade 1
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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