A Multi Center Study of Sexual Toxicities After Radiotherapy

ID#: NCT05394428

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: October 04, 2022

End Date: August 31, 2026

Contact Information:
Deborah C Marshall, MD MAS
201-500-5522
Natasha Gironimi, MPH
646-984-9321
Summary: 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:

Inclusion Criteria:

- Patients with female sexual organs ages 18 and older.

- Patients must meet at least one of the following two criteria:

- have been sexually active in the 36 months prior to initiating cancer treatment.

- have the intent to be sexually active in the 24 months following treatment..

- Patients must be able to provide consent and be willing to participate.

- Patients 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:

- planned for or undergone extensive pelvic surgery (e.g. pelvic exenteration, non-TME techniques, or surgeries otherwise affecting pudendal neurovasculature);

- have clinically or radiologically detectable widespread metastasis;

- have limited life expectancy due to comorbid disease;

- have a personal history of cancer other than non-melanoma skin cancer in the last 5 years;

- have 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).

- have persistent, infectious gastroenteritis, colitis or gastritis;

- have persistent or chronic diarrhea of unknown etiology; have recurrent or untreated GI infection (clostridium difficile or H. pylori);

- have current or recurrent vaginal infection;

- have current or recent antibiotic use (within 2 months). Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the STAR Study. Patients may be enrolled on the STAR Study concurrently with another study or clinical trial.
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