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.
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
Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
Patients who have received prior pelvic radiation
Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)
Endometrial cancer or endometrial hyperplasia
Single group
Biospecimen Collection
Procedure/SurgeryUndergo vaginal swab sample collection
Prasterone
DrugGiven vaginally
Survey Administration
Other interventionAncillary studies
Incidence of grade 2 or higher adverse events
Will consider this study feasible if 80% of participants are able to complete 12 weeks of dehydroepiandrosterone (DHEA) without grade 2 or higher adverse events other than vaginal discharge or due to vaginal discharge that is felt to be too bothersome to the participant.
Change in vaginal microbiome
RNA sequencing of vaginal swab samples will be performed. The RNA sequencing will measure quantities of microbes.
Change in vaginal exam findings (diameter)
Vaginal diameter will be assessed using vaginal dilators ranging in size from small, medium, and large.
Change in vaginal exam findings (length)
Vaginal length will be determined by measuring from vaginal cuff, apex, or cervix to posterior fourchette (mark will be made on dilator in the vagina and then measured when dilator is removed). If a dilator cannot be placed, a cotton swab will be placed into the vagina due to stenosis or poor patient tolerance and measured at the level of the posterior fourchette.
Change in sexual function
Sexual function will be measured using the Female Sexual Functioning Index (FSFI).The FSFI is a 19-item self -reported instrument that has been previously validated to measure sexual functioning in women in clinical trials. It measures six domains of sexual functioning including arousal, orgasm, satisfaction and pain. Overall test-retest reliability coefficients are high for each domain, and the internal consistency is high with a Cronbach's alpha of 0.82 and higher. The total maximum score is 36 with a higher score indicating better functioning.
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