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

Last updated: February 10, 2026
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Rectal Cancer

Uterine Disorders

Treatment

Biospecimen Collection

Survey Administration

Prasterone

Clinical Study ID

NCT07407647
OSU-25055
NCI-2026-00035
  • Ages > 50
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receivingexternal beam radiation alone, or both external beam radiation and brachytherapywith curative intent (Participants will be consented and enrolled prior to startingtreatment 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 12months or bilateral oophorectomy

Exclusion

Exclusion Criteria:

  • Patients with scleroderma, mixed connective tissue disorder, and lupus will beexcluded

  • Patients who have received prior pelvic radiation

  • Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatmentrelated toxicity)

  • Endometrial cancer or endometrial hyperplasia

  • Use of estrogen alone injectable or progestin implant therapy with 3 months beforestudy entry

  • Use of estrogen pellet or progestin injectable drug within 6 months before studyentry

  • Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeksbefore study entry

  • Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +/-progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such asblack cohosh in the 4 weeks before study entry. Intravaginal moisturizers andlubricants prior to enrollment are permitted

  • History of breast cancer

  • Patients receiving palliative radiation therapy

  • Patients who do not meet criteria for menopause

Study Design

Total Participants: 25
Treatment Group(s): 3
Primary Treatment: Biospecimen Collection
Phase: 2
Study Start date:
March 01, 2026
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

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