[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100624285","phase-2-vaginal-dhea-to-improve-vaginal-health-after-radiation-for-women-with-gynecologic-anal-or-rectal-cancer-100624285",false,"NCT07407647","Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer","Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation","Inclusion Criteria:\n\n* 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)\n* Concurrent or prior chemotherapy is allowed\n* Any prior gynecologic surgery is permitted\n* Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted\n* Subject must be menopausal, which is defined as age \\> 50 with no menses for 12 months or bilateral oophorectomy\n\nExclusion Criteria:\n\n* Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded\n* Patients who have received prior pelvic radiation\n* Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)\n* Endometrial cancer or endometrial hyperplasia\n* Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry\n* Use of estrogen pellet or progestin injectable drug within 6 months before study entry\n* Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeks before study entry\n* Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +\u002F- 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\n* History of breast cancer\n* Patients receiving palliative radiation therapy\n* Patients who do not meet criteria for menopause","FEMALE","50 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31],"Anal Carcinoma","Cervical Carcinoma","Malignant Female Reproductive System Neoplasm","Rectal Carcinoma","Vaginal Carcinoma","Vulvar Carcinoma","RECRUITING","2026-04-16",{"date":35,"type":36},"2026-04-21","ACTUAL",{"date":38,"type":36},"2026-03-12",{"date":40,"type":20},"2026-12-31",{"name":42,"class":43},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":5},"100568808","phase-2-hpv-vaccine-imiquimod-and-metformin-combination-trial-100568808","NCT06686043","HPV Vaccine, Imiquimod, and Metformin Combination Trial","A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers","HPV-VIM","Inclusion Criteria:\n\n* Participants must have histologically confirmed locally advanced or metastatic cervical carcinoma (Stage IB2-IVB), vaginal, or vulvar carcinoma (Stage II-IVB), AND not be considered a primary surgical candidate. Patients offered neoadjuvant therapy may be enrolled if they respond and receive chemoradiation.\n* Participants must have measurable disease, per Recist criteria. See Section 12 (Measurement of Effect) for the evaluation of measurable disease. Radiological evaluation shall occur within approximately 30 days prior to enrollment initiation and start of radiation.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Participants must be ≥ 18 years of age\n* Participants must have adequate organ function within 28 days of registration, defined as follows: - Absolute neutrophil count ≥ 1,500\u002FµL - Platelets ≥ 100,000\u002FµL - Hemoglobin ≥ 9 g\u002FdL - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN - Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\n* Participants receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.\n* Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n* Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. Females of non-childbearing potential is defined as follows (by other than medical reasons): - ≥45 years of age and has not had menses for \\>1 year, post-hysterectomy, post-bilateral oophorectomy, post external beam radiation of 6 Gy to the pelvis, or post-tubal ligation.\n* Participants must agree to not breastfeed during the study.\n* Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n* Participants must be eligible for chemoradiation treatment in the opinion of the treating investigator.\n* Participants who are HIV+ must have CD4 counts \\>200\u002FdL and demonstrate documented Highly active antiretroviral therapy (HAART) compliance m. Participant must have CT (chest\u002Fabdomen\u002Fpelvis) or PET-CT, within 56 days of registration.\n* Participants must be newly diagnosed.\n* Standard chemoradiation using external beam radiation therapy (EBRT) and brachytherapy is permitted for cervical or vaginal carcinoma, and chemoradiation with EBRT for vulvar carcinoma. A lesion must be readily accessible for intratumoral tumor injection.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Patients who have untreated, new or progressive brain metastases or leptomeningeal disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.\n* Patients with uncontrolled intercurrent illness.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because cervical carcinoma or vulva carcinoma patients have undergone treatment rendering the patient infertile. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cervical carcinoma or vulva carcinoma, breastfeeding should be discontinued.","18 Years","64 Years",{"count":56,"type":20},85,[23],"The goal of this clinical trial is to explore whether additional treatments can help strengthen the participant's immune system to fight cancer caused by the Human Papillomavirus (HPV), a virus spread through intimate skin-to-skin contact. The trial will also monitor the safety of these treatments. The main questions it aims to answer are:\n\nDoes the combination of treatments help the participant's body fight the cancer more effectively when used alongside standard therapy? What side effects or medical issues arise when using these experimental treatments? Researchers will use three experimental therapies along with the participant's standard treatment to find out if these therapies work better together than standard treatment alone.\n\nParticipants will:\n\nReceive HPV vaccinations during the 2nd and 4th week of radiation, and again at weeks 8, 10, 12, and 16 after completing radiation.\n\nHave blood samples taken, tumor cells brushed from the surface, and imiquimod cream applied during each visit.\n\nTake a daily metformin pill and apply an imiquimod suppository three times a week for two weeks after each visit.",[27,30,31,60],"HPV (Human Papillomavirus)-Associated Carcinoma",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"metformin","HPV","Imiquimod","Human Papillomavirus 9-valent Vaccine","Recombinant","Cytobrush","cervical cancer","vaginal cancer","vulvar cancer","chemoradiation","tumor","immunotherapy","metastatic","intratumoral","Endometrial cancer","2024-11-11",{"date":79,"type":36},"2024-11-13",{"date":81,"type":36},"2024-08-23",{"date":83,"type":20},"2028-08-23",{"name":85,"class":43},"Baylor College of Medicine"]