This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of the vagina and symptoms including vaginal dryness, vaginal burning and itching, vaginal bleeding, pain or burning during urination, and pain during sexual intercourse. DHEA is a type of hormone replacement therapy. It is use to improve symptoms in women during menopause and may be effective in treating these symptoms for women who have received radiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07407647.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Allison Marie Quick
Phone: 614-293-8415
PRIMARY OBJECTIVE:
I. To determine the feasibility and tolerability of dehydroepiandrosterone (DHEA) in the post radiation setting for women with gynecologic and gastrointestinal cancers.
SECONDARY OBJECTIVES:
I. To identify changes from baseline to post-radiation in the vaginal microbiome in women with gynecologic and gastrointestinal cancers receiving vaginal DHEA.
II. To identify those who may respond to vaginal DHEA based on their pretreatment microbiome.
III. To correlate changes in vaginal exam findings, sexual function, and quality of life with changes in the vaginal microbiome.
OUTLINE:
Patients receive DHEA vaginally once daily (OD) for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorAllison Marie Quick