Vaginal DHEA to improve vaginal health after pelvic radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.