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Recruiting NCT07407647

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

Phase II Interventional Anal Carcinoma Cervical Carcinoma Malignant Female Reproductive System Neoplasm Rectal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Prasterone, Survey Administration.
Who it may be relevant to
Registry conditions: Anal Carcinoma, Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Rectal Carcinoma. Basic parameters: from 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation

Overview

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.

Detailed description

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo vaginal swab sample collection
  • Drug Prasterone
    Given vaginally
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Incidence of grade 2 or higher adverse events [Time frame: From start of treatment to 12 weeks]
Secondary outcome measures (7)
  • Change in vaginal microbiome [Time frame: From baseline to 12 weeks]
  • Change in vaginal exam findings (diameter) [Time frame: From baseline to 12 weeks]
  • Change in vaginal exam findings (length) [Time frame: From baseline to 12 weeks]
  • Change in sexual function [Time frame: From baseline to 12 weeks]
  • Change in Vulvovaginal symptoms (Vaginal Assessment Scale) [Time frame: From baseline to 12 weeks]
  • Change in Vulvovaginal symptoms (Vulvar Assessment Scale) [Time frame: From baseline to 12 weeks]
  • Change in Sexual Distress [Time frame: From baseline to 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07407647 · OSU-25055 · NCI-2026-00035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗