Phase
Condition
Colorectal Cancer
Rectal Cancer
Uterine Disorders
Treatment
Biospecimen Collection
Survey Administration
Prasterone
Clinical Study ID
Ages > 50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receivingexternal beam radiation alone, or both external beam radiation and brachytherapywith curative intent (Participants will be consented and enrolled prior to startingtreatment 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 12months or bilateral oophorectomy
Exclusion
Exclusion Criteria:
Patients with scleroderma, mixed connective tissue disorder, and lupus will beexcluded
Patients who have received prior pelvic radiation
Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatmentrelated toxicity)
Endometrial cancer or endometrial hyperplasia
Use of estrogen alone injectable or progestin implant therapy with 3 months beforestudy entry
Use of estrogen pellet or progestin injectable drug within 6 months before studyentry
Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeksbefore study entry
Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +/-progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such asblack cohosh in the 4 weeks before study entry. Intravaginal moisturizers andlubricants prior to enrollment are permitted
History of breast cancer
Patients receiving palliative radiation therapy
Patients who do not meet criteria for menopause
Study Design
Study Description
Connect with a study center
Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting

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