New study aims to uncover why some women have worse sexual side effects from radiation
NCT ID NCT05394428
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is observing 300 women with female sexual organs who are receiving radiotherapy for certain cancers. Researchers want to understand why some patients have more sexual side effects than others. They will track sexual quality of life and look at radiation doses to find patterns. The goal is to create models that predict side effects and eventually improve treatment techniques.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could lead to better ways to predict and reduce sexual side effects from radiotherapy, improving quality of life for female cancer patients.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly help participants. Results may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult female patients treated with pelvic radiation therapy
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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M.D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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