Understanding sexual side effects after radiotherapy in female cancer patients
Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort
This study is trying to understand how radiotherapy and other cancer treatments affect sexual health in women with cancer to help improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT05394428 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how radiotherapy and other cancer treatments affect sexual function in female patients with malignant neoplasms. Participants will provide consent for access to their medical records and complete quality of life and toxicity questionnaires before and after treatment, as well as every six months for two years. Additionally, blood samples will be collected to explore potential biomarkers related to sexual side effects. The goal is to improve understanding of these side effects and develop predictive models and interventions to enhance patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer who are planned to receive pelvic radiotherapy.
Not a fit: Patients who have undergone extensive pelvic surgery or have widespread metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sexual side effects in female cancer patients, enhancing their quality of life.
How similar studies have performed: Other studies have explored sexual side effects in cancer treatment, but this specific approach focusing on predictive models and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Deborah C Marshall, MD MAS — Icahn School of Medicine at Mount Sinai
- Study coordinator: Deborah C Marshall, MD MAS
- Email: star.consortium@mssm.edu
- Phone: 201-500-5522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.