Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
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. O…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after treatment is completed) * Concurrent or prior chemotherapy is allowed * Any prior gynecologic surgery is permitted * Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted * Subject must be menopausal, which is defined as age \> 50 with no…
Interventions
- ProcedureBiospecimen Collection
Undergo vaginal swab sample collection
- DrugPrasterone
Given vaginally
- OtherSurvey Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio