RECRUITING

A Multi Center Study of Sexual Toxicities After Radiotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort

Quick Facts

Study Start:2022-10-04
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05394428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with female sexual organs ages 18 and older.
  2. * Patients must meet at least one of the following two criteria:
  3. * have been sexually active in the 36 months prior to initiating cancer treatment.
  4. * have the intent to be sexually active in the 24 months following treatment..
  5. * Patients must be able to provide consent and be willing to participate.
  6. * 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.
  1. * planned for or undergone extensive pelvic surgery (e.g. pelvic exenteration, non-TME techniques, or surgeries otherwise affecting pudendal neurovasculature);
  2. * have clinically or radiologically detectable widespread metastasis;
  3. * have limited life expectancy due to comorbid disease;
  4. * have a personal history of cancer other than non-melanoma skin cancer in the last 5 years;
  5. * 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).
  6. * have persistent, infectious gastroenteritis, colitis or gastritis;
  7. * have persistent or chronic diarrhea of unknown etiology; have recurrent or untreated GI infection (clostridium difficile or H. pylori);
  8. * have current or recurrent vaginal infection;
  9. * have current or recent antibiotic use (within 2 months).

Contacts and Locations

Study Contact

Deborah C Marshall, MD MAS
CONTACT
201-500-5522
star.consortium@mssm.edu
Natasha Gironimi, MPH
CONTACT
646-984-9321
natasha.gironimi@mountsinai.org

Principal Investigator

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

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
M.D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-04
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-10-04
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Neoplasms