Back to search results

Observational Study on Sexual Toxicities After Radiotherapy

This study aims to understand how radiation therapy (radiotherapy) and other cancer treatments affect sexual function in women with cancer. Researchers want to find out why some patients experience more sexual side effects than others after radiotherapy. There are no interventions or treatments being tested in this study. You would be helping to establish a group of patients whose sexual quality of life will be tracked for two years. The goal is to improve our understanding of these side effects, which could lead to better ways to prevent or reduce them and improve the quality of life for female cancer patients. This study is open to women aged 18 and older who have female sexual organs and have been sexually active recently or intend to be sexually active after treatment. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 300 participants. It is not testing a new treatment but rather observing the effects of existing treatments.
What's involved
You would give consent for access to your medical records, complete health and quality of life questionnaires before treatment, after treatment, every six months for two years, and then yearly. You would also provide one blood sample.
Compensation
Not stated in the trial record.
Follow-up
Your sexual quality of life will be measured for two years, and you will be asked to complete questionnaires yearly thereafter as long as you are enrolled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05394428

A Multi Center Study of Sexual Toxicities After Radiotherapy

Recruiting
Not specifiedAges 18+Observational
Icahn School of Medicine at Mount Sinai
~300 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Establish Sexual Quality of Life Cohort
Measured over 2 years

Conditions

Malignant Neoplasms

Explore related trials

Anal CarcinomaCervical CarcinomaMalignant Uterine NeoplasmRectal CarcinomaSolid NeoplasmVaginal CarcinomaVulvar Carcinoma

Where it's being run

3 sites across 3 states
Georgia1
New York1
Texas1

Study leadership

  • Deborah C Marshall, MD MAS · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Deborah C Marshall, MD MAS
[email protected]
201-500-5522
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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).

What this trial measures

  • Establish Sexual Quality of Life Cohort2 years

    Establish a cohort of patients with female sexual organs receiving radiotherapy