Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• 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 menses for 12 months or bilateral oophorectomy

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Supportive care (DHEA)
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.
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov