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New treatment option for Anal Carcinoma
Official title Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
ClinicalTrials.gov ID: NCT07407647
What this study is testing
What is Prasterone?
Prasterone is an investigational medicine, given as an once-daily, being studied as a potential treatment for anal carcinoma.
Also referred to as 17-Hormoforin, Dehydroepiandrosterone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and...
- 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 likely can't join 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
See the full eligibility 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...
- 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
- 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...
- History of breast cancer
- Patients receiving palliative radiation therapy
- Patients who do not meet criteria for menopause
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.