Actively Recruiting
A Multi Center Study of Sexual Toxicities After Radiotherapy
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-11-22
300
Participants Needed
3
Research Sites
203 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multi Center Study of Sexual Toxicities After Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with female sexual organs aged 18 years and older
- Patients must have been sexually active in the 36 months before starting cancer treatment or intend to be sexually active in the 24 months following treatment
- Patients must be able to provide consent and willing to participate
- Patients must have primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer planned for pelvic radiotherapy
- Patients must have an Eastern Cooperative Oncology Group performance status of 2 or less
You will not qualify if you...
- Planned for or undergone extensive pelvic surgery affecting pudendal neurovasculature
- Clinically or radiologically detectable widespread metastasis
- Limited life expectancy due to other diseases
- Personal history of cancer other than non-melanoma skin cancer within last 5 years
- Contraindications or strong relative contraindications to radiotherapy, such as pregnancy, lactation, genetic susceptibility, connective tissue disorders, inflammatory or irritable bowel disease, or prior pelvic radiotherapy
- Persistent infectious gastroenteritis, colitis, or gastritis
- Persistent or chronic diarrhea of unknown cause
- Recurrent or untreated gastrointestinal infection (Clostridium difficile or H. pylori)
- Current or recurrent vaginal infection
- Current or recent antibiotic use within 2 months
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
3
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Deborah C Marshall, MD MAS
CONTACT
N
Natasha Gironimi, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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