Clinical trial NCT03876860: An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
Official title: An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Cervical Cancer
Vaginal Stricture
Radiation Toxicity
Keywords: Vaginal dilator
Vaginal stenosis
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial with two arms including control arm and experimental arm
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Participant Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Vaginal Length
timeFrame: 12 months
measure: Vaginal stenosis grading scale
timeFrame: 12 months
measure: Change in female sexual function
timeFrame: 12 months
measure: Discomfort with pelvic exams
timeFrame: 12 months
measure: Discomfort with dilator use
timeFrame: 12 months
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Margaret R Liotta, DO
role: PRINCIPAL_INVESTIGATOR
References:
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