RECRUITING

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

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

This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. The intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. The new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. We hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

Official Title

An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial

Quick Facts

Study Start:2018-09-24
Study Completion:2024-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03876860

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. * Diagnosis of endometrial or cervical cancer
  2. * Undergoing external beam radiation therapy with or without brachytherapy
  3. * English-speaking
  1. * History or current presence of fistula

Contacts and Locations

Study Contact

Danielle M Krause, MD
CONTACT
7082164033
dkrause@lumc.edu
Margaret R Liotta, DO
CONTACT
7083272104
mliotta@lumc.edu

Principal Investigator

Margaret R Liotta, DO
PRINCIPAL_INVESTIGATOR
Loyola University

Study Locations (Sites)

Loyola University Medical Center
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Margaret Liotta

  • Margaret R Liotta, DO, PRINCIPAL_INVESTIGATOR, Loyola University

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 Date2018-09-24
Study Completion Date2024-04-01

Study Record Updates

Study Start Date2018-09-24
Study Completion Date2024-04-01

Terms related to this study

Keywords Provided by Researchers

  • Vaginal dilator
  • Vaginal stenosis

Additional Relevant MeSH Terms

  • Endometrial Cancer
  • Cervical Cancer
  • Vaginal Stricture
  • Radiation Toxicity