Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
Recruiting
Phase 2Interventional Study
Anal CarcinomaCervical CarcinomaMalignant Female Reproductive System NeoplasmRectal CarcinomaVaginal CarcinomaVulvar Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
25 (estimated)
Sponsor
Ohio State University Comprehensive Cancer Center · Other
Who this trial is looking for
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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 th…
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.
Trial Locations
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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 inte…
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
Contacts
The Ohio State University Comprehensive Cancer Center
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