A Phase 2 interventional study of Biospecimen Collection and Prasterone in Anal Carcinoma, Cervical Carcinoma and Malignant Female Reproductive System Neoplasm, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care
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.
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 25 is below the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Exclusion Criteria:
Patients receive DHEA vaginally QD for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study.
Procedure: Biospecimen Collection · Drug: Prasterone · Other: Survey Administration
Undergo vaginal swab sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given vaginally
Also known as: 17-Hormoforin, Dehydroepiandrosterone, Dehydroisoandrosterone, DHEA, Diandron, Fidelin, GL701, Therapeutic Dehydroepiandrosterone
Ancillary 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.
Time frame: From start of treatment to 12 weeks
Change in vaginal microbiome
RNA sequencing of vaginal swab samples will be performed. The RNA sequencing will measure quantities of microbes.
Time frame: From baseline to 12 weeks
Change in vaginal exam findings (diameter)
Vaginal diameter will be assessed using vaginal dilators ranging in size from small, medium, and large.
Time frame: From baseline to 12 weeks
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.
Time frame: From baseline to 12 weeks
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.
Time frame: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vaginal Assessment Scale)
The Vaginal Assessment Scale (VAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
Time frame: From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vulvar Assessment Scale)
The Vulvar Assessment Scale (VuAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
Time frame: From baseline to 12 weeks
Change in Sexual Distress
Sexual distress will be measured using the Female Sexual Distress Scale Revised (FSDS-R), which has been shown to effectively measure sexually related personal distress in women. Higher scores indicate more distress. The revised version with 13 items was used in this study.
Time frame: From baseline to 12 weeks
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Studies of the drug tested here: Dehydroepiandrosterone
Ohio State University Comprehensive Cancer Center →