Status:
RECRUITING
A Multi Center Study of Sexual Toxicities After Radiotherapy
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Emory University
M.D. Anderson Cancer Center
Conditions:
Malignant Neoplasms
Eligibility:
FEMALE
18+ years
Brief 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 ...
Detailed Description
Participants will be asked too: * Give consent for past and future access to medical record information. At each timepoint, the study team will collect data from electronic medical record about (demo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05394428
Start Date
October 4 2022
End Date
August 31 2026
Last Update
November 22 2024
Active Locations (3)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030