Comparing Megestrol Acetate Alone and with Metformin to Prevent Endometrial Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04576104

Provider View

This study is exploring whether using the drug megestrol acetate alone or combined with metformin can better prevent uterine pre-cancer from developing into endometrial cancer. Megestrol acetate is a hormone-blocking drug, while metformin is known for its potential anti-cancer effects.

Patient Parameters

Program Overview

This phase II clinical trial is investigating if megestrol acetate, a drug that blocks certain hormones, can prevent the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. The study also examines if adding metformin, a drug with anti-cancer properties, to megestrol acetate can be more effective than using megestrol acetate alone.

Description

The main goal of this study is to see how well megestrol acetate, with or without metformin, can reduce the growth of pre-cancerous cells in the uterus. Participants will receive either megestrol acetate alone or in combination with metformin for 21-35 days before their planned surgery or placement of a hormone-releasing device in the uterus. Researchers will measure changes in cell growth and protein levels in the pre-cancerous tissue to evaluate the effectiveness of the treatments.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take megestrol acetate by mouth twice a day for 21-35 days.
  • Group 2: Will take both megestrol acetate and metformin by mouth twice a day for 21-35 days.

Both groups will undergo a biopsy on the day of their planned procedure. After completing the study treatment, participants will be monitored for up to 42 days to assess the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with endometrial intraepithelial neoplasia (EIN) or similar conditions within the last three months.
  • Must be 18 years or older.
  • Must be in good general health with a performance status that allows for daily activities.
  • Must have normal liver and kidney function based on blood tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with controlled hepatitis B or C can participate.
  • Diabetic patients must have well-controlled blood sugar levels.
  • Must be willing to undergo surgery or use a hormone-releasing device for treatment.
  • Women of childbearing potential must use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Current use of certain hormonal therapies or medications that affect hormone levels, except for specific low-dose progestins.
  • Current or recent use of metformin or certain other diabetes medications.
  • Participation in another clinical trial within 30 days.
  • Allergies to megestrol acetate or metformin.
  • Serious health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • History of blood clots or certain cardiovascular conditions.
  • Diabetic women on insulin must monitor their blood sugar closely.
  • Women with alcohol use disorders.
  • Use of certain medications that interact with metformin.
  • Cancer survivors with active disease.

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