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
Listed as NCT07407647, this observational or N/A phase trial focuses on Anal Carcinoma and Cervical Carcinoma and remains actively recruiting participants. Sponsored by Ohio State University Comprehensive Cancer Center, it has been updated 2 times since 2026, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
2 versions recorded-
Apr 21, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
-
Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE2
First recorded
Eligibility 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.
Contact Information
- Ohio State University Comprehensive Cancer Center
For direct contact, visit the study record on ClinicalTrials.gov .