Recruiting
Phase 2

DHEA

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07407647

Conditions

Anal Carcinoma

Cervical Carcinoma

Malignant Female Reproductive System Neoplasm

Rectal Carcinoma

Vaginal Carcinoma

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Prasterone

Survey Administration

Study Details

Brief 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.

Conditions

Anal Carcinoma

Cervical Carcinoma

Malignant Female Reproductive System Neoplasm

Rectal Carcinoma

Vaginal Carcinoma

Study ID

NCT07407647

Start date

Mar 12, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo vaginal swab sample collection

Prasterone

Given vaginally

Survey Administration

Ancillary studies

Primary outcome measure

  • Incidence of grade 2 or higher adverse events [ Time Frame: From start of treatment to 12 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Allison M. Quick, MD

614-293-8415Allison.Quick@osumc.edu

Principal Investigator:

Allison M. Quick, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-04-21.