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An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

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ClinicalTrials.gov Identifier: NCT03876860
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Margaret Liotta, Loyola University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Cervical Cancer Vaginal Stricture Radiation Toxicity Device: Silicone Dilator Device: Standard Dilator Not Applicable

Detailed Description:
Pelvic radiotherapy and vaginal brachytherapy play an integral role in managing gynecological malignancies, including endometrial and cervical cancer. Radiation-induced vaginal stenosis is a well recognized complication of radiation therapy and can result in painful, inadequate pelvic exams and sexual dysfunction. Current recommendations to prevent and manage vaginal stenosis include regular use of vaginal dilators, with our institutional recommendation being three times weekly for 10 minutes. Compliance varies among studies but is generally perceived to be low. Limited literature exists regarding ways to improve adherence and correct use of vaginal dilators. The goal of this study is to enhance the standard vaginal dilator model to improve patient outcomes. Eligibility includes women with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. Patients will be randomized to either the standard vaginal dilator or an enhanced model. The enhanced dilator model includes the addition of a silicone band placed at the desired depth of vaginal dilator insertion, aimed to aide in correct insertion length. The primary aim of the study is patient adherence to vaginal dilator use. Secondary aims include vaginal length, CTCAE v5.0 grading scale for vaginal stricture, sexual function, self-reported comfort with use, and discomfort during office pelvic exams. Outcomes will be obtained based on physician reporting and patient surveys. All analyses will be completed by a biostatistician in the Clinical Research Office using SAS version 9.4.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial with two arms including control arm and experimental arm
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Dilator
Participants in control arm (active comparator) will receive standard vaginal dilator with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes
 Device: Standard Dilator
Standard vaginal dilator
Experimental: Silicone Dilator
Participants in experimental arm will receive standard vaginal dilator with addition of silicone ring with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes
 Device: Silicone Dilator
Addition of silicone band to standard vaginal dilator


Outcome Measures
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Primary Outcome Measures :
  1. Participant Adherence [ Time Frame: 12 months ]
    Number of participants who use the vaginal dilator at least three times per week


Secondary Outcome Measures :
  1. Vaginal Length [ Time Frame: 12 months ]
    Vaginal length (in centimeters) measured using a POP-Q wooden stick

  2. Vaginal stenosis grading scale [ Time Frame: 12 months ]
    The vaginal stenosis grading scale is an ordinal scale ranging from 0 (no vaginal stenosis) to 3 (severe vaginal stenosis) as defined by the Common Terminology Criteria for Adverse Events Version 5.0 - vaginal stricture.

  3. Change in female sexual function [ Time Frame: 12 months ]
    The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning. The baseline FSFI score is subtracted from the 12-month follow-up FSFI score for each participant.

  4. Discomfort with pelvic exams [ Time Frame: 12 months ]
    Discomfort with pelvic exams is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

  5. Discomfort with dilator use [ Time Frame: 12 months ]
    Discomfort with use of the dilator is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of endometrial or cervical cancer
  • Undergoing external beam radiation therapy with or without brachytherapy
  • English-speaking

Exclusion Criteria:

  • History or current presence of fistula
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876860


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

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Danielle Krause, MD    708-216-4033    dkrause@lumc.edu   
Contact: Margaret Liotta, DO    7083272104    mliotta@lumc.edu   
Principal Investigator: Margaret Liotta, DO         
Sponsors and Collaborators
Margaret Liotta
Investigators
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Principal Investigator: Margaret R Liotta, DO Loyola University
More Information
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Publications:

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Responsible Party: Margaret Liotta, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03876860    
Other Study ID Numbers: 211334
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Margaret Liotta, Loyola University:
Vaginal dilator
Vaginal stenosis
Additional relevant MeSH terms:
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Endometrial Neoplasms
Constriction, Pathologic
Pathological Conditions, Anatomical
Uterine Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases