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Vaginal DHEA for Vaginal Health After Radiation

This study is testing if vaginal DHEA (dehydroepiandrosterone), a hormone replacement therapy, can improve vaginal health for women who have received radiation for gynecologic (cancers of the female reproductive system), anal, or rectal cancer. Radiation can cause vaginal dryness, burning, itching, and pain, similar to menopause. Researchers want to see if vaginal DHEA can help with these symptoms and improve the vaginal microbiome (the community of bacteria and other organisms in the vagina). You may be eligible if you are a woman aged 50 or older with anal, rectal, cervical, vaginal, or vulvar cancer who has received or is receiving radiation. The study aims to see how well vaginal DHEA is tolerated and if it helps improve vaginal health.

Study design
This is an interventional study with a planned enrollment of 25 women. It is a single-arm study, meaning all participants receive the same intervention.
What's involved
You would receive vaginal DHEA once daily for 3 months. You would also have vaginal swab samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) from the start of treatment up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07407647

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

Recruiting
PHASE2Ages 50+InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~25 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Biospecimen CollectionPrasteroneSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 2 or higher adverse events
Measured over From start of treatment to 12 weeks

Conditions

Anal Carcinoma
Cervical Carcinoma
Malignant Female Reproductive System Neoplasm
Rectal Carcinoma
Vaginal Carcinoma
Vulvar Carcinoma

Explore related trials

Anal CarcinomaCervical CarcinomaRectal CarcinomaSolid NeoplasmVaginal CarcinomaVulvar Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Allison M Quick, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of grade 2 or higher adverse eventsFrom start of treatment to 12 weeks

    Will consider this study feasible if 80% of participants are able to complete 12 weeks of dehydroepiandrosterone (DHEA) without grade 2 or higher adverse events other than vaginal discharge or due to vaginal discharge that is felt to be too bothersome to the participant.