Vaginal DHEA for Gynecologic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Allison M Quick, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for menopausal women over 50 who have had anal, rectal, cervical, vaginal, or vulvar cancer and are undergoing radiation. They can join whether they've had gynecologic surgery or chemotherapy. However, they must wait until after their radiation treatment to start the trial intervention.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DHEA vaginally once daily for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prasterone
Trial Overview
The study is testing vaginal DHEA's ability to improve vaginal health in women post-radiation therapy for certain cancers. It will assess how this hormone replacement therapy affects symptoms like dryness and pain during intercourse by collecting biospecimens and survey responses.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
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