Endometrial Cancer Recurrence in Patients Taking Metformin

Recurrent Endometrial Carcinoma Clinical Trial

Official title:

Endometrial Cancer Recurrence in Patients Taking Metformin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05192850
• Other study ID #: 1849612-1
• Status: Active, not recruiting
• Start date: December 27, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Given the early literature available and its biological plausibility as an inhibitor of the mammalian target of rapamycin (mTOR) protein, it is hypothesized that women with endometrial cancer who take metformin for non-cancer related reasons have a lower cancer recurrence rate compared to women not taking metformin. The primary goal of this study is to determine whether metformin use is associated with a decrease in the rate of endometrial cancer recurrence. Secondary objectives are to assess whether women with endometrial cancer taking metformin have longer progression free survival and overall survival than those that do not take metformin.

Description:

This is a retrospective chart review study. Medical records are reviewed and data collected through the hospital's electronic medical record (EMR). Participants are women that had definitive treatment for endometrial cancer between 2016-2020 at WellSpan York Hospital Department of Gynecologic Oncology. Participants are identified and their chart reviewed for demographic data of age, race, comorbid conditions, and use of metformin. Possible confounding information is documented, including chemotherapy status, radiotherapy status, cancer and tumor type, grade, and stage, available genetics information, medications at the time of cancer diagnosis, and medication durations. Those patients who had cancer recurrence are identified. Recurrence data including type, time interval, additional treatment are collected. Recurrence is defined as any recurrence validated by clinical, imaging and histological data and can be identified based on the cancer registry. Recurrence rate in participants that took metformin vs. those that did not is calculated. Time to endometrial cancer recurrence is calculated. Progression free survival and overall survival are calculated. Statistical analysis is performed to compare each of these outcomes between participants who took metformin vs. those that did not.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Participants with endometrial cancer of all histologies treated in the WellSpan system from 2016-2020

Exclusion Criteria:

• Participants who underwent palliative treatment for endometrial cancer

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Recurrence
• Recurrent Endometrial Carcinoma

Intervention

Drug:
• Metformin use
As an observational study, this is past exposure to metformin that occurred during the study period

Locations

Country	Name	City	State
United States	WellSpan	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

Esposito K, Chiodini P, Capuano A, Bellastella G, Maiorino MI, Giugliano D. Metabolic syndrome and endometrial cancer: a meta-analysis. Endocrine. 2014 Feb;45(1):28-36. doi: 10.1007/s12020-013-9973-3. Epub 2013 May 3. — View Citation

Lee TY, Martinez-Outschoorn UE, Schilder RJ, Kim CH, Richard SD, Rosenblum NG, Johnson JM. Metformin as a Therapeutic Target in Endometrial Cancers. Front Oncol. 2018 Aug 28;8:341. doi: 10.3389/fonc.2018.00341. eCollection 2018. — View Citation

Meireles CG, Pereira SA, Valadares LP, Rego DF, Simeoni LA, Guerra ENS, Lofrano-Porto A. Effects of metformin on endometrial cancer: Systematic review and meta-analysis. Gynecol Oncol. 2017 Oct;147(1):167-180. doi: 10.1016/j.ygyno.2017.07.120. Epub 2017 Jul 29. — View Citation

Tang YL, Zhu LY, Li Y, Yu J, Wang J, Zeng XX, Hu KX, Liu JY, Xu JX. Metformin Use Is Associated with Reduced Incidence and Improved Survival of Endometrial Cancer: A Meta-Analysis. Biomed Res Int. 2017;2017:5905384. doi: 10.1155/2017/5905384. Epub 2017 Mar 20. — View Citation

Tseng CH. Metformin and endometrial cancer risk in Chinese women with type 2 diabetes mellitus in Taiwan. Gynecol Oncol. 2015 Jul;138(1):147-53. doi: 10.1016/j.ygyno.2015.03.059. Epub 2015 Apr 22. — View Citation

Xie W, Li T, Yang J, Shang M, Xiao Y, Li Q, Yang J. Metformin use and survival outcomes in endometrial cancer: a systematic review and meta-analysis. Oncotarget. 2017 Aug 22;8(42):73079-73086. doi: 10.18632/oncotarget.20388. eCollection 2017 Sep 22. — View Citation

Zhang ZJ, Li S. The prognostic value of metformin for cancer patients with concurrent diabetes: a systematic review and meta-analysis. Diabetes Obes Metab. 2014 Aug;16(8):707-10. doi: 10.1111/dom.12267. Epub 2014 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial Cancer Recurrence	This is the identification of whether metformin use is associated with endometrial cancer recurrence.	2016-2020
Secondary	Progression Free Survival	This is the identification of whether metformin use is associated with improved progression free survival of endometrial cancer.	2016-2020
Secondary	Overall Survival	This is the identification of whether metformin use is associated with improved overall survival of endometrial cancer.	2016-2020