Study on Megestrol Acetate With or Without Pterostilbene for Treating Endometrial Cancer in Patients Undergoing Hysterectomy

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03671811

Provider View

This clinical trial is exploring whether the combination of megestrol acetate and pterostilbene, or megestrol acetate alone, is more effective in treating endometrial cancer in patients scheduled for a hysterectomy. The study aims to see if these treatments can help stop cancer cell growth before surgery.

Patient Parameters

Program Overview

This study is investigating how well megestrol acetate, a chemotherapy drug, works with or without pterostilbene, a natural antioxidant found in blueberries and grapes, in treating endometrial cancer. The goal is to see if these treatments can reduce cancer cell growth in patients who are about to have a hysterectomy. Researchers want to find out if adding pterostilbene to megestrol acetate makes the treatment more effective.

Description

The main goal of this study is to compare the effects of megestrol acetate (MA) combined with pterostilbene (PTE) versus MA alone on the growth of cancer cells in patients with endometrial cancer who are scheduled for a hysterectomy. Researchers will look at how these treatments affect cancer cell growth during the period before surgery.

Additionally, the study will explore how these treatments affect the cancer's appearance under a microscope and identify any biological markers that might help select patients for future studies.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take pterostilbene and megestrol acetate by mouth twice a day for three weeks, unless the disease worsens or side effects become unacceptable.
  • Group 2: Will take megestrol acetate by mouth twice a day for three weeks, unless the disease worsens or side effects become unacceptable.

After finishing the treatment, participants will have a follow-up visit six weeks later.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Willing to have a biopsy or tissue sample taken during surgery after treatment.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Diagnosed with endometrial cancer or complex atypical hyperplasia of the endometrium.
  • Eligible for a total hysterectomy, with or without removal of ovaries and fallopian tubes.
  • Starting the pre-surgery treatment period, with surgery planned.
  • Platelet count of at least 100,000/mm³ (no recent platelet transfusions unless due to disease).
  • Total bilirubin, AST, and ALT levels within specified limits.
  • Kidney function with creatinine clearance of at least 60 mL/min.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have taken pterostilbene supplements within 30 days before starting the study.
  • Have taken certain other supplements like resveratrol, genistein, or quercetin within 30 days before starting the study.
  • Have received chemotherapy for endometrial cancer.
  • Have allergies or sensitivities to similar medications or ingredients.
  • Have unstable heart conditions, such as recent heart attack or severe heart failure.
  • Have had a recent blood clot or stroke within the past six months.
  • Have Cushing's syndrome.
  • Have an active infection requiring intravenous treatment.
  • Have a known history of HIV or active hepatitis B or C infection.
  • Unable to swallow pills or capsules.
  • Have any other condition that might make participating in the study unsafe or difficult, such as severe infections, intestinal blockage, or psychological issues.
  • May not be able to follow all study procedures due to logistical or compliance issues.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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