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Hormone Therapy

Megestrol + Metformin for Endometrial Cancer Prevention

Phase 2
Recruiting
Led By Emma Barber
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
Must be a candidate and accepting of surgical management of EIN with planned hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial is testing whether a combination of two drugs, megestrol acetate and metformin, is more effective than megestrol acetate alone in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer.

Who is the study for?
This trial is for adults with a pre-cancerous condition of the uterus called endometrial intraepithelial neoplasia (EIN), who are planning to have a hysterectomy. They must be in good health, not pregnant, and willing to use birth control if they can have children. People with certain viral infections must be on treatment with an undetectable viral load.Check my eligibility
What is being tested?
The study is testing whether taking megestrol acetate alone or combined with metformin prevents EIN from turning into uterine cancer better than just megestrol acetate. Participants will receive these medications before their planned surgery to remove the uterus.See study design
What are the potential side effects?
Megestrol may cause weight gain, increased blood pressure, and blood clots. Metformin can lead to stomach issues like diarrhea and nausea, as well as a rare but serious condition called lactic acidosis especially in people who drink alcohol excessively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on long-term antiviral treatment for herpes.
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I am willing to undergo a hysterectomy for my endometrial condition.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I agree to use birth control or abstain from sex during the study.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My diabetes is under control with a recent A1c below 8.0.
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I am 18 years old or older.
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My hepatitis B virus load is undetectable with treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with a precancerous condition of the uterus within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days post planned procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days post planned procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Ki-67 positive cells
Secondary outcome measures
Changes in protein expression
Other outcome measures
Ki-67 expression

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (megestrol acetate, metformin hydrochloride)Experimental Treatment4 Interventions
Prior to standard of care planned procedure, patients receive megestrol acetate PO BID and metformin hydrochloride extended-release PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.
Group II: Arm I (megestrol acetate)Active Control3 Interventions
Prior to standard of care planned procedure, patients receive megestrol acetate PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~840
Megestrol Acetate
2007
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,345 Total Patients Enrolled
75 Trials studying Endometrial Cancer
72,425 Patients Enrolled for Endometrial Cancer
Emma BarberPrincipal InvestigatorNorthwestern University

Media Library

Megestrol Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04576104 — Phase 2
Endometrial Cancer Research Study Groups: Arm II (megestrol acetate, metformin hydrochloride), Arm I (megestrol acetate)
Endometrial Cancer Clinical Trial 2023: Megestrol Acetate Highlights & Side Effects. Trial Name: NCT04576104 — Phase 2
Megestrol Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576104 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this clinical trial recruiting participants?

"To meet the requirements of this trial, 50 qualified individuals need to participate. They can do so at multiple facilities like Northwestern University in Chicago and Duke Univesity Medial Center in Durham."

Answered by AI

Have past experiments been conducted utilizing Megestrol Acetate?

"Currently, 176 studies are taking place looking into the effects of Megestrol Acetate with 45 in Phase 3. Pittsburgh is where most of these trials take place but 1982 other sites have research on this medication going on as well."

Answered by AI

How many medical facilities are offering this clinical trial?

"There are 6 sites offering participation in this medical trial, including Northwestern University in Chicago, Duke University Medical Center in Durham, and UNC Lineberger Comprehensive Cancer Center in Chapel Hill. Additionally, 3 other locations provide the same opportunity to join the study."

Answered by AI

Has Megestrol Acetate received governmental authorization from the Food and Drug Administration?

"Megestrol Acetate's safety is estimated to be a 2, as the current Phase 2 trial has data suggesting it can protect patients from harm but does not have any evidence of efficacy."

Answered by AI

What medicinal purposes is Megestrol Acetate regularly employed for?

"Megestrol Acetate is a viable solution for those who have not responded to metformin. This drug can additionally be used to address conditions such as AIDS, cachexia and fatigue from lack of exercise."

Answered by AI

Are there any available positions to join this clinical trial right now?

"According to clinicaltrials.gov, the time-frame of this medical study is now open and accepting participants. The trial was initiated on September 17th 2021 and has experienced recent edits made as recently as November 30th 2022."

Answered by AI
~11 spots leftby Nov 2024