25 Participants Needed

Vaginal DHEA for Gynecologic Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of vaginal DHEA (Prasterone) in improving vaginal health for women who have undergone radiation treatment for gynecologic, anal, or rectal cancer. Radiation can cause issues like dryness, burning, and pain, similar to menopause symptoms. DHEA, a hormone therapy, may alleviate these problems. Women who are menopausal, have received specific cancer treatments, and experience these symptoms might be suitable candidates for this study. Participants will use a DHEA treatment for three months and provide vaginal swab samples during the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use estrogen or progestin therapies, DHEA, or certain vaginal treatments for a period before starting the study. Check with the trial team for details on your specific medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using vaginal DHEA (a hormone) is generally safe for improving vaginal health. In one study, women who used vaginal DHEA for 12 weeks reported no major safety issues. The treatment was well-tolerated, with only mild side effects. Another study found that using DHEA vaginally alleviated symptoms like dryness and discomfort over 6 months without significant problems. These studies suggest that vaginal DHEA could be a safe option for managing vaginal symptoms after radiation treatment.12345

Why do researchers think this study treatment might be promising?

Unlike standard treatments for gynecologic cancer, which often involve surgery, radiation, or chemotherapy, Prasterone (DHEA) offers a unique approach by being administered vaginally. This method targets the affected area directly, potentially minimizing systemic side effects. Prasterone is a precursor hormone that can be converted into estrogen and other hormones locally, which may help improve symptoms and quality of life without the broader hormonal impacts. Researchers are excited about this treatment because it provides a potentially safer, more localized option for patients, focusing on targeted supportive care.

What evidence suggests that vaginal DHEA might be an effective treatment for improving vaginal health after radiation in gynecologic cancer?

Research has shown that vaginal DHEA (prasterone) can improve vaginal health in women after menopause or cancer treatment. One study found that using vaginal DHEA for 12 weeks significantly enhanced sexual health and reduced symptoms like dryness, burning, and pain during sex. Another study demonstrated that cancer survivors using DHEA experienced better vaginal health and comfort without a significant rise in estrogen levels, which is important for safety. In this trial, participants will receive DHEA vaginally for 3 months. These findings suggest that DHEA could help treat vaginal issues caused by radiation treatment for gynecologic cancer.678910

Who Is on the Research Team?

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Allison M Quick, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for menopausal women over 50 who have had anal, rectal, cervical, vaginal, or vulvar cancer and are undergoing radiation. They can join whether they've had gynecologic surgery or chemotherapy. However, they must wait until after their radiation treatment to start the trial intervention.

Inclusion Criteria

I have cancer in the anal, rectal, cervical, vaginal, or vulvar area and will undergo radiation with the aim to cure.
I have had chemotherapy before or am currently undergoing it.
I am over 50 and have not had a period for 12 months or have had both ovaries removed.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DHEA vaginally once daily for 3 months

12 weeks
Regular visits for vaginal swab sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prasterone

Trial Overview

The study is testing vaginal DHEA's ability to improve vaginal health in women post-radiation therapy for certain cancers. It will assess how this hormone replacement therapy affects symptoms like dryness and pain during intercourse by collecting biospecimens and survey responses.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (DHEA)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

Evaluating the efficacy of vaginal dehydroepiandosterone for ...

PM and DHEA improved vaginal symptoms at 12 weeks. However, vaginal DHEA, 6.5 mg, significantly improved sexual health. Vaginal DHEA warrants further ...

N10C1 Public Results Summary 2021 0903 FINAL

Study results. These results are for postmenopausal women with a history of breast or gynecologic cancer who had completed chemotherapy and ...

Study Details | NCT01376349 | Prasterone ...

RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA ...

Impact of vaginal dehydroepiandosterone (DHEA) on ...

The aim of this study was to evaluate the impact of vaginal DHEA on vaginal atrophy symptoms and sexual function. Methods: A controlled, ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35343852/

Safety of prasterone in breast cancer survivors treated with ...

Conclusion: Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at ...

Systemic and local effects of vaginal dehydroepiandrosterone ...

This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover and vaginal cytology in women with a cancer history.

Retrospective Analysis of Efficacy and Safety of Vaginal ...

Our study demonstrates that, over a 6-month follow-up, local estrogens, topical DHEA and ospemifene are effective in improving genitourinary ...

208470Orig1s000 - accessdata.fda.gov

The safety and efficacy data presented in primary 12-week clinical Trial ERC-231 included in the application, received on October 16, 2015.

Treatment of Urogenital Symptoms in Individuals With a ...

This document has been updated to review the safety and efficacy of newer hormonal treatment options as well as nonhormonal modalities.

Study Details | NCT07407647 | Vaginal DHEA to Improve ...

This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with ...