Actively Recruiting
Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-21
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of vaginal DHEA, a hormone replacement therapy, to improve vaginal health in women who have undergone radiation treatment for gynecologic, anal, or rectal cancers. Radiation to the abdomen can change the vaginal microbiome and cause symptoms such as dryness, burning, itching, bleeding, and pain during urination or sexual intercourse. This phase II trial aims to test the feasibility and side effects of vaginal DHEA for managing these symptoms in menopausal women after radiation therapy. Participants will receive daily vaginal doses of DHEA for three months, provided their disease does not progress and they do not experience unacceptable side effects. Throughout the study, vaginal swab samples will be collected to analyze changes in the vaginal microbiome. The study will also explore how the treatment affects vaginal exam findings, sexual function, and quality of life. During the trial, women will undergo regular vaginal exams, complete surveys about sexual function and symptoms, and provide vaginal swabs for microbiome analysis. Researchers will monitor for adverse events and changes in vaginal health and sexual distress from the start of treatment through 12 weeks. The total treatment period is three months, with ongoing assessments to evaluate the safety and impact of vaginal DHEA.
CONDITIONS
Brief Title
Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone or with brachytherapy with curative intent
- Concurrent or prior chemotherapy allowed
- Any prior gynecologic surgery allowed
- Rectal surgery including lower anterior resection and abdominoperineal resection allowed
- Menopausal women defined as age over 50 with no menses for 12 months or bilateral oophorectomy
You will not qualify if you...
- Patients with scleroderma, mixed connective tissue disorder, or lupus
- Patients who have received prior pelvic radiation
- Undiagnosed abnormal genital bleeding unrelated to current diagnosis or treatment
- History of endometrial cancer or endometrial hyperplasia
- Use of estrogen alone injectable or progestin implant therapy within 3 months before study entry
- Use of estrogen pellet or progestin injectable drug within 6 months before study entry
- Use of oral estrogen, progestin, DHEA, or intrauterine progestin within 8 weeks before study entry
- Use of vaginal estrogen, transdermal estrogen with or without progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments within 4 weeks before study entry
- History of breast cancer
- Patients receiving palliative radiation therapy
- Patients who do not meet menopause criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive vaginal DHEA once daily for 3 months in the absence of disease progression or unacceptable toxicity. Vaginal swab sample collection and surveys are conducted throughout the treatment period.
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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