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Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort
The purpose of this research is to understand how radiotherapy and other cancer treatments impact sexual function in female cancer patients and to try to answer a question about why some patients who receive radiotherapy are more likely to have side effects than others. The results of this study may improve our understanding of why sexual side effects occur and in turn develop predictive models and biomarkers of sexual side effects and other side effects that may impact sexual function. The results of this study may also lead to improvements in the techniques used to deliver radiotherapy or the development of interventions that will prevent or reduce sexual side effects and improve quality of life for female patients with cancer.
Eligibility Criteria
Inclusion Criteria
- 1Patients with female sexual organs ages 18 and older.
- 2Patients must meet at least one of the following two criteria:
- 3have been sexually active in the 36 months prior to initiating cancer treatment.
- 4have the intent to be sexually active in the 24 months following treatment..
- 5Patients must be able to provide consent and be willing to participate.
- 6Patients must have primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer planned to receive pelvic radiotherapy.\*\* Patients must have an Eastern Cooperative Oncology Group performance status \<=2.
Exclusion Criteria
- 1planned for or undergone extensive pelvic surgery (e.g. pelvic exenteration, non-TME techniques, or surgeries otherwise affecting pudendal neurovasculature);
- 2have clinically or radiologically detectable widespread metastasis;
- 3have limited life expectancy due to comorbid disease;
- 4have a personal history of cancer other than non-melanoma skin cancer in the last 5 years;
- 5have contraindications or strong relative contraindications to radiotherapy at baseline as determined by the treating radiation oncologist (pregnancy, lactation, genetic susceptibility to cancer from ionizing radiotherapy, connective tissue disorders, inflammatory/irritable bowel disease, history of prior pelvic radiotherapy).
- 6have persistent, infectious gastroenteritis, colitis or gastritis;
- 7have persistent or chronic diarrhea of unknown etiology; have recurrent or untreated GI infection (clostridium difficile or H. pylori);
- 8have current or recurrent vaginal infection;
- 9have current or recent antibiotic use (within 2 months).
- 10Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the STAR Study.
- 11Patients may be enrolled on the STAR Study concurrently with another study or clinical trial.
Locations
3 sites participating in this study
Emory University
Atlanta, Georgia 30322
Mylin Torres, MD, BA
Icahn School of Medicine at Mount Sinai
New York, New York 10029
Deborah C Marshall, MD
M.D. Anderson Cancer Center
Houston, Texas 77030
Anuja Jhingran, MD