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

NCT07407647 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-25055NCI-2026-00035
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 2 or higher adverse events

  Will consider this study feasible if 80% of participants are able to complete 12 weeks of dehydroepiandrosterone (DHEA) without grade 2 or higher adverse events other than vaginal discharge or due to vaginal discharge that is felt to be too bothersome to the participant.

  From start of treatment to 12 weeks

Secondary Outcomes (7)

• Change in vaginal microbiome

  From baseline to 12 weeks

• Change in vaginal exam findings (diameter)

  From baseline to 12 weeks

• Change in vaginal exam findings (length)

  From baseline to 12 weeks

• Change in sexual function

  From baseline to 12 weeks

• Change in Vulvovaginal symptoms (Vaginal Assessment Scale)

  From baseline to 12 weeks

Study Arms (1)

Supportive care (DHEA)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Prasterone; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo vaginal swab sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Supportive care (DHEA)

Prasterone DRUG

Given vaginally

Also known as: 17-Hormoforin, Dehydroepiandrosterone, Dehydroisoandrosterone, DHEA, Diandron, Fidelin, GL701, Therapeutic Dehydroepiandrosterone

Supportive care (DHEA)

Survey Administration OTHER

Ancillary studies

Supportive care (DHEA)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Anus Neoplasms; Uterine Cervical Neoplasms; Rectal Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Specimen Handling; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Allison M Quick, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 12, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)