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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Prasterone
  • Survey Administration

Treatment groups

25 Participants
are divided into 1 treatment group