An Endometrial Cancer Chemoprevention Study of Metformin

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical research study is to learn about the effects of metformin and/or a program called "lifestyle intervention" on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese (both are risk factors for endometrial cancer). Researchers also want to learn how insulin levels will be affected by metformin, diet and/or exercise.

Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a condition in which the body makes insulin but does not use it properly. It is often referred to as "pre-diabetes". Many people with insulin resistance have high levels of both sugar and insulin in their blood at the same time, which have been reported in patients with endometrial cancer.

In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Lifestyle intervention is made up of a series of in-person sessions where you meet with a coach to discuss strategies for losing weight and ways to increase physical activity. It also consists of materials designed to help you lose weight and will offer opportunities for supervised exercise.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. For this study, only women will be enrolled.

2. Body Mass Index (BMI) > or = 30 kg/m2

3. Not frankly diabetic, as measured by a fasting blood glucose

4. Demonstrate hyperinsulinemia with a QUICK I value

5. Age >/= 50 and

6. Zubrod Performance Scale 0-1

7. Hemoglobin >/= 10 g/dl

8. TSH 0.27 - 4.20 µlU/mL

9. Menopause as defined as no menses for 1 year and/or FSH >/= 25.8 mIU/ml

10. Must be able to read, write, and speak English.

11. Must have a Primary Care Provider (PCP).

Exclusion Criteria:

1. Prior hysterectomy or endometrial ablation

2. ALT >/r = 2.0x Upper Limit of Normal (ULN)

3. Serum creatinine > /= 1.4 mg/dl

4. Triglycerides (fasting) >/ = 400

5. Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.

6. Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change.

7. Participant reported history of congestive heart failure

8. Prior treatment with Metformin

9. Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.

10. Known allergy to Metformin or other biguanide (Proguanil).

11. Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months

12. Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene

13. Hormone replacement therapy within the last 6 months

14. Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer

15. Patients who have had prior radiation to the pelvis