RecruitingPhase 2NCT07407647

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

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

25 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

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

Sex: FEMALEMin Age: 50 Years

Inclusion Criteria5

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 Criteria11

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