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An Endometrial Cancer Chemoprevention Study of Metformin
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Gynecology | Drug: Metformin Other: Placebo Procedure: Endometrial Biopsy Behavioral: Lifestyle Intervention Behavioral: Questionnaires | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | An Endometrial Cancer Chemoprevention Study of Metformin Versus No Treatment in Women With a Body Mass Index (BMI) >/= 30 kg.m2 and Hyperinsulinemia |
- Effect of Metformin and/or Lifestyle Intervention on Biomarkers. [ Time Frame: 4 months ]Differences in Ki-67 and other biomarkers analyzed using a 2x2 ANOVA. Other biomarkers examined include a) a panel of genes relevant to estrogen dependent endometrial proliferation, hyperplasia and cancer using Q-PCR, b) biomarkers specific to the effect of metformin treatment (phospho-AMPKa, phospho-ACC, phospho-mTOR and phospho-S6 ribosomal protein and c) potential biomarkers of modulation of insulin sensitivity on the human endometrial proteome using reverse phase protein arrays (RPPA).
| Estimated Enrollment: | 100 |
| Actual Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2019 |
| Estimated Primary Completion Date: | May 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
Participants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. |
Drug: Metformin
Participants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Experimental: Placebo + Lifestyle Intervention
Placebo taken by mouth twice daily for 4, 30 day cycles. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
|
Other: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
Other Name: sugar pill
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Lifestyle Intervention
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Experimental: Metformin + Lifestyle Intervention
Participants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period. |
Drug: Metformin
Participants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Lifestyle Intervention
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Placebo Comparator: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
|
Other: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
Other Name: sugar pill
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- For this study, only women will be enrolled.
- Body Mass Index (BMI) > or = 30 kg/m2
- Not frankly diabetic, as measured by a fasting blood glucose </=126 mg/dL.
- Demonstrate hyperinsulinemia with a QUICK I value </= 0.357.
- Age >/= 50 and </= 65
- Zubrod Performance Scale 0-1
- Hemoglobin >/= 10 g/dl
- TSH 0.27 - 4.20 µlU/mL
- Menopause as defined as no menses for 1 year and/or FSH >/= 25.8 mIU/ml
- Must be able to read, write, and speak English.
- Must have a Primary Care Provider (PCP).
Exclusion Criteria:
- Prior hysterectomy or endometrial ablation
- ALT >/r = 2.0x Upper Limit of Normal (ULN)
- Serum creatinine > /= 1.4 mg/dl
- Triglycerides (fasting) >/ = 400
- Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
- 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.
- Participant reported history of congestive heart failure
- Prior treatment with Metformin
- Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.
- Known allergy to Metformin or other biguanide (Proguanil).
- Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months
- Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene
- Hormone replacement therapy within the last 6 months
- Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer
- Patients who have had prior radiation to the pelvis
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01697566
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Karen H. Lu, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01697566 History of Changes |
| Other Study ID Numbers: |
2011-0739 5P50CA098258 ( U.S. NIH Grant/Contract ) NCI-2013-00834 ( Registry Identifier: NCI CTRP ) |
| Study First Received: | September 28, 2012 |
| Last Updated: | June 16, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
|
Gynecology Endometrial Cancer Chemoprevention Obese Body Mass Index (BMI) >/= 35 kg.m2 Post-menopausal Hyperinsulinemia |
Metformin Placebo Sugar pill Lifestyle intervention Diet Exercise |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Metformin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 19, 2017