Actively Recruiting

Phase 2
Age: 50Years +
FEMALE
NCT07407647

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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-21

25

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone or with brachytherapy with curative intent
  • Concurrent or prior chemotherapy allowed
  • Any prior gynecologic surgery allowed
  • Rectal surgery, including lower anterior resection and abdominoperineal resection, allowed
  • Menopausal women defined as age over 50 with no menses for 12 months or bilateral oophorectomy
Not Eligible

You will not qualify if you...

  • Patients with scleroderma, mixed connective tissue disorder, or lupus
  • Patients who have received prior pelvic radiation
  • Undiagnosed abnormal genital bleeding unrelated to current diagnosis or treatment toxicity
  • Endometrial cancer or endometrial hyperplasia
  • Use of estrogen alone injectable or progestin implant therapy within 3 months before study entry
  • Use of estrogen pellet or progestin injectable drug within 6 months before study entry
  • Use of oral estrogen, progestin, DHEA, or intrauterine progestin within 8 weeks before study entry
  • Use of vaginal estrogen, transdermal estrogen with or without progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments within 4 weeks before study entry
  • History of breast cancer
  • Patients receiving palliative radiation therapy
  • Patients who do not meet criteria for menopause

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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