Vaginal DHEA to improve vaginal health after pelvic radiation
Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
This phase II trial tests whether daily vaginal DHEA can help reduce vaginal dryness, pain, and related symptoms in menopausal women after radiation for gynecologic, anal, or rectal cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07407647 on ClinicalTrials.gov |
What this trial studies
This single-center phase II feasibility trial enrolls menopausal women receiving curative pelvic radiation for anal, rectal, cervical, vaginal, or vulvar cancers and initiates vaginal DHEA after completion of radiation. Participants self-administer prasterone (DHEA) vaginally once daily for three months while the study team collects vaginal swabs and patient-reported surveys on sexual function and quality of life. The primary focus is on feasibility and tolerability of the intervention, with secondary analyses examining changes in the vaginal microbiome and whether baseline microbiome patterns predict response. Clinical vaginal exam findings and symptom scores will be correlated with microbiome changes to explore mechanisms of benefit.
Who should consider this trial
Good fit: Menopausal women (age >50 with 12 months without menses or those with bilateral oophorectomy) receiving external beam radiation with or without brachytherapy for anal, rectal, cervical, vaginal, or vulvar cancer are ideal candidates.
Not a fit: Patients with prior pelvic radiation, connective tissue disorders like scleroderma or lupus, endometrial cancer/hyperplasia, or ongoing undiagnosed genital bleeding are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, vaginal DHEA could reduce post-radiation vaginal dryness, pain, and improve sexual function and quality of life for affected women.
How similar studies have performed: Topical vaginal DHEA (prasterone) has demonstrated benefit for menopausal vaginal atrophy in prior studies, but its safety and effectiveness specifically after pelvic radiation are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded * Patients who have received prior pelvic radiation * Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity) * Endometrial cancer or endometrial hyperplasia * Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry * Use of estrogen pellet or progestin injectable drug within 6 months before study entry * Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeks before study entry * Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +/- progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such as black cohosh in the 4 weeks before study entry. Intravaginal moisturizers and lubricants prior to enrollment are permitted * History of breast cancer * Patients receiving palliative radiation therapy * Patients who do not meet criteria for menopause
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Allison M Quick, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.