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

April 16, 2026 updated by: Allison Quick, Ohio State University Comprehensive Cancer Center

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility and tolerability of dehydroepiandrosterone (DHEA) in the post radiation setting for women with gynecologic and gastrointestinal cancers.

SECONDARY OBJECTIVES:

I. To identify changes from baseline to post-radiation in the vaginal microbiome in women with gynecologic and gastrointestinal cancers receiving vaginal DHEA.

II. To identify those who may respond to vaginal DHEA based on their pretreatment microbiome.

III. To correlate changes in vaginal exam findings, sexual function, and quality of life with changes in the vaginal microbiome.

OUTLINE:

Patients receive DHEA vaginally once daily (OD) for 3 months in the absence of disease progression or unacceptable toxicity. Patients undergo vaginal swab sample collection throughout the study.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Allison M. Quick, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo vaginal swab sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Prasterone
Given vaginally
Other Names:
  • DHEA
  • Dehydroepiandrosterone
  • 17-Hormoforin
  • Dehydroisoandrosterone
  • Diandron
  • Fidelin
  • GL701
  • Therapeutic Dehydroepiandrosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 2 or higher adverse events
Time Frame: From 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.
From start of treatment to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaginal microbiome
Time Frame: From baseline to 12 weeks
RNA sequencing of vaginal swab samples will be performed. The RNA sequencing will measure quantities of microbes.
From baseline to 12 weeks
Change in vaginal exam findings (diameter)
Time Frame: From baseline to 12 weeks
Vaginal diameter will be assessed using vaginal dilators ranging in size from small, medium, and large.
From baseline to 12 weeks
Change in vaginal exam findings (length)
Time Frame: From baseline to 12 weeks
Vaginal length will be determined by measuring from vaginal cuff, apex, or cervix to posterior fourchette (mark will be made on dilator in the vagina and then measured when dilator is removed). If a dilator cannot be placed, a cotton swab will be placed into the vagina due to stenosis or poor patient tolerance and measured at the level of the posterior fourchette.
From baseline to 12 weeks
Change in sexual function
Time Frame: From baseline to 12 weeks
Sexual function will be measured using the Female Sexual Functioning Index (FSFI).The FSFI is a 19-item self -reported instrument that has been previously validated to measure sexual functioning in women in clinical trials. It measures six domains of sexual functioning including arousal, orgasm, satisfaction and pain. Overall test-retest reliability coefficients are high for each domain, and the internal consistency is high with a Cronbach's alpha of 0.82 and higher. The total maximum score is 36 with a higher score indicating better functioning.
From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vaginal Assessment Scale)
Time Frame: From baseline to 12 weeks
The Vaginal Assessment Scale (VAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
From baseline to 12 weeks
Change in Vulvovaginal symptoms (Vulvar Assessment Scale)
Time Frame: From baseline to 12 weeks
The Vulvar Assessment Scale (VuAS) is a recently validated clinical measurement tools to identify vulvovaginal symptoms. Patients are asked about specific symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia and are asked to rate them as mild, moderate, or severe. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean score of the items. A lower score indicates better function.
From baseline to 12 weeks
Change in Sexual Distress
Time Frame: From baseline to 12 weeks
Sexual distress will be measured using the Female Sexual Distress Scale Revised (FSDS-R), which has been shown to effectively measure sexually related personal distress in women. Higher scores indicate more distress. The revised version with 13 items was used in this study.
From baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Allison M Quick, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-25055
  • NCI-2026-00035 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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