Progestins for Endometrial Cancer

This trial explores the effects of two hormone treatments, megestrol acetate and micronized progesterone, on endometrial cancer and precancerous uterine conditions. The goal is to determine how these hormone therapies, which resemble the natural hormone progesterone, perform in treating these conditions before surgery. Participants will receive either megestrol acetate or micronized progesterone to assess which treatment proves more effective. Women diagnosed with endometrial cancer or atypical endometrial hyperplasia, who are scheduled for surgery, may be suitable candidates for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you need to stop taking your current medications. However, if you have taken progestin or anti-estrogen therapy in the last 3 months, you cannot participate.

Research has shown that both megestrol acetate and micronized progesterone have been studied for their safety in humans. Megestrol acetate, often used to treat certain cancers, is generally safe. Most people tolerate it well, though some might experience mild side effects like weight gain or an upset stomach.

Micronized progesterone, a natural hormone commonly used in hormone replacement therapy, usually protects the lining of the uterus well when used properly. However, evidence suggests it might increase the risk of uterine cancer when combined with estrogen in certain hormone therapies. This risk typically arises with long-term use and specific combinations, not with short-term or standalone use of micronized progesterone.

Most treatments for endometrial cancer, like surgery or chemotherapy, focus on removing or targeting cancer cells directly. However, the treatments in this trial are unique because they use hormone therapy to potentially manage cancer growth. The progesterone-only hormone replacement therapy utilizes micronized progesterone, which could offer a more natural and targeted approach to slowing cancer progression. Additionally, the use of megestrol acetate, a progestin, is noteworthy because it provides an alternative hormonal pathway to influence the cancer. Researchers are excited about these treatments because they might offer a less invasive option with fewer side effects compared to traditional treatments.

Research has shown that certain medications, such as megestrol acetate, can help treat endometrial cancer. Studies have found that megestrol acetate acts like the natural hormone progesterone, which can slow or stop cancer growth. In this trial, some participants will receive megestrol acetate. The trial also examines another form of progesterone, called micronized progesterone. Although often used in hormone therapies, some studies suggest it might increase the risk of issues with the uterine lining. This trial aims to compare the effectiveness of these two treatments in managing endometrial cancer before surgery.¹⁵⁶⁷⁸