Study of Vaginal DHEA for Women Over 50 After Radiation for Gynecologic and Gastrointestinal Cancers Evaluating Safety, Tolerability, and Vaginal Health Improvements

What this Trial Is About

Researchers are evaluating the use of vaginal DHEA, a hormone replacement therapy, to improve vaginal health in women who have undergone radiation treatment for gynecologic, anal, or rectal cancers. Radiation to the abdomen can change the vaginal microbiome and cause symptoms such as dryness, burning, itching, bleeding, and pain during urination or sexual intercourse. This phase II trial aims to test the feasibility and side effects of vaginal DHEA for managing these symptoms in menopausal women after radiation therapy. Participants will receive daily vaginal doses of DHEA for three months, provided their disease does not progress and they do not experience unacceptable side effects. Throughout the study, vaginal swab samples will be collected to analyze changes in the vaginal microbiome. The study will also explore how the treatment affects vaginal exam findings, sexual function, and quality of life. During the trial, women will undergo regular vaginal exams, complete surveys about sexual function and symptoms, and provide vaginal swabs for microbiome analysis. Researchers will monitor for adverse events and changes in vaginal health and sexual distress from the start of treatment through 12 weeks. The total treatment period is three months, with ongoing assessments to evaluate the safety and impact of vaginal DHEA.

Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer