RecruitingNot Applicable

A Multi Center Study of Sexual Toxicities After Radiotherapy

United States300 participantsStarted 2022-10-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Establish Sexual Quality of Life Cohort

Timeframe: 2 years

Trial details

NCT IDNCT05394428

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-31

Contact for this trial

Deborah C Marshall, MD MAS

201-500-5522 star.consortium@mssm.edu

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