drugset / Trial / NCT03671811

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

NCT03671811 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2019-01-21
Primary completion
2022-12-12
Completion
2027-02-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I (Pterostilbene, Megestrol Acetate) vs Arm II (Megestrol Acetate); p = 0.9; t-test, 1 sided NCT03671811 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Megestrol Acetate Other / unclassified 80 mg Oral
Subject Pterostilbene Small molecule 100 mg Oral