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NCT03671811Active, not recruitingPhase 2

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

Open-Label Randomized Phase II Trial of Megestrol Acetate With or Without Pterostilbene in Patients With Endometrial Cancer Scheduled for Hysterectomy

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
44 (actual)
First submitted
27 Jul 2018
Start date
21 Jan 2019
Primary completion date
12 Dec 2022
Lead sponsor
City of Hope Medical Center
NCT number
NCT03671811

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 44
  • From 21 Jan 2019 to the primary completion date, 12 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pterostilbene supplements within 30 days prior to day 1 of protocol therapy
  • Any of the following phytochemical-based supplements within 30 days prior to day 1 of protocol therapy: resveratrol, genistein, and quercetin
  • Chemotherapy for EC

Other illness

  • 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
  • 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

Other

  • Inability to swallow tablets/capsules
  • 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)

Who the study is looking for

  • Documented informed consent of the participant and/or legally authorized representative
  • Willing to undergo an intraoperative biopsy/or standard of care tissue collection during surgery, following completion of treatment with MA +/- PTE
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Histologically confirmed EC or complex atypical hyperplasia of the endometrium
  • Candidate for a total hysterectomy with or without bilateral salpingo-oophorectomy
  • About to initiate preoperative window period, with planned hysterectomy scheduled
  • Platelets \>= 100,000/mm\^3
    • NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  • Total bilirubin =\< 1.5 X upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =\< 1.5 x ULN
  • Alanine aminotransferase (ALT) =\< 1.5 x ULN
  • Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
  • Women of childbearing potential: negative urine or serum pregnancy test in premenopausal women. Postmenopausal women do not need to undergo a pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.