NCT05394428 A Multi Center Study of Sexual Toxicities After Radiotherapy
| NCT ID | NCT05394428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Malignant Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-10-04 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-10-04 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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: * 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.
Contact & Investigator
Deborah C Marshall, MD MAS
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05394428 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Malignant Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05394428 currently recruiting?
Yes, NCT05394428 is actively recruiting participants. Contact the research team at star.consortium@mssm.edu for enrollment information.
Where is the NCT05394428 trial being conducted?
This trial is being conducted at Atlanta, United States, New York, United States, Houston, United States.
Who is sponsoring the NCT05394428 clinical trial?
NCT05394428 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Deborah C Marshall, MD MAS at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 300 participants.