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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo vaginal swab sample collection
• Prasterone — DRUG
  Given vaginally
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Mar 12, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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