RecruitingPhase 2NCT07407647

Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

25 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a vaginal hormone treatment called DHEA (a mild hormonal suppository) can improve vaginal dryness, discomfort, and sexual health in women who have gone through pelvic radiation for cancers such as anal, rectal, cervical, vaginal, or vulvar cancer. **You may be eligible if...** - You have been diagnosed with anal, rectal, cervical, vaginal, or vulvar cancer - You are receiving or have received pelvic radiation with the goal of cure - You have had chemotherapy before or during radiation (this is allowed) - You are menopausal (over 50 with no period for 12 months, or had both ovaries removed) **You may NOT be eligible if...** - You have scleroderma, lupus, or mixed connective tissue disorder - You have had prior pelvic radiation - You have endometrial cancer or endometrial hyperplasia - You have unexplained vaginal bleeding - You are currently using hormonal medications (estrogen, progestin, or DHEA) - You have a history of breast cancer - You are receiving radiation for palliative (not curative) purposes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo vaginal swab sample collection

DRUGPrasterone

Given vaginally

OTHERSurvey Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07407647


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