Megestrol Acetate + Pterostilbene for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byThanh H. Dellinger

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well megestrol acetate with or without pterostilbene works in treating patients with endometrial cancer undergoing hysterectomy. Drugs used in chemotherapy, such as megestrol acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pterostilbene is an antioxidant found in blueberries or grapes, and it has been shown to be effective in killing tumor cells and reducing cancer burden. It is not yet known whether giving megestrol acetate with or without pterostilbene may work better in treating patients with endometrial cancer.

Eligibility Criteria

This trial is for women with endometrial cancer or complex atypical hyperplasia who are fit enough for surgery (ECOG 0-2) and have normal liver and kidney function. They must be able to swallow pills, not pregnant, without serious heart conditions, infections needing IV treatment, HIV, hepatitis B/C, recent thromboembolism/stroke/MI or taking certain supplements.

Inclusion Criteria

Platelets >= 100,000/mm^3

I am a candidate for a surgery to remove my uterus, and possibly my ovaries and fallopian tubes.

I am scheduled for a hysterectomy soon.

+9 more

Exclusion Criteria

Allergic reaction/hypersensitivity to similar agents, excipients

Unstable cardiac disease as defined by one of the following: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertensive emergency/urgency (defined as systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 120 mmHg), active or history of recent thromboembolism or stroke, within the past 6 months, Cushing's syndrome, acute infection requiring systemic (intravenous) treatment, known history of human immunodeficiency virus (HIV) infection, known active hepatitis B or C infection, inability to swallow tablets/capsules, any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc, prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

I have not taken pterostilbene supplements in the last 30 days.

+2 more

Participant Groups

The study is testing the effectiveness of megestrol acetate (a chemotherapy drug) with or without pterostilbene (an antioxidant found in blueberries/grapes) in patients undergoing hysterectomy for endometrial cancer. It aims to determine if adding pterostilbene improves outcomes.

2Treatment groups

Experimental Treatment

Group I: Arm II (megestrol acetate)Experimental Treatment1 Intervention

Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.

Group II: Arm I (pterostilbene, megestrol acetate)Experimental Treatment2 Interventions

Patients receive pterostilbene PO BID and megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.

Megestrol Acetate is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Megace for: