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Endometrial CancerNCT03876860

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

A study testing Silicone Dilator and Standard Dilator in people with Endometrial Cancer and Cervical Cancer, run by Margaret Liotta at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Silicone Dilator and Standard Dilator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
24 Sep 2018to 1 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • History or current presence of fistula

Trial locations and contacts

1 site in 1 country.

Danielle M Krause, MD contact

7082164033

dkrause@lumc.edu

Margaret R Liotta, DO contact

7083272104

mliotta@lumc.edu

United States1 site, 1 recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Danielle Krause, MD, 708-216-4033, dkrause@lumc.edu

    Margaret Liotta, DO, 7083272104, mliotta@lumc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Silicone Dilator, Standard Dilator
Keywords
Vaginal dilator, Vaginal stenosis
Medical subject headings
Endometrial Neoplasms, Uterine Cervical Neoplasms, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silicone DilatorDevice

    Addition of silicone band to standard vaginal dilator

  • Standard DilatorDevice

    Standard vaginal dilator

Study groups in NCT03876860
Study groupRoleWhat they receive
Standard DilatorActive comparatorParticipants 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
Receives: Device: Standard Dilator
Silicone DilatorExperimentalParticipants 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
Receives: Device: Silicone Dilator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Adherence

    Number of participants who use the vaginal dilator at least three times per week

    Measured: 12 months

Secondary outcomes (5)

  1. Vaginal Length

    Vaginal length (in centimeters) measured using a POP-Q wooden stick

    Measured: 12 months

  2. Vaginal stenosis grading scale

    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.

    Measured: 12 months

  3. Change in female sexual function

    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.

    Measured: 12 months

  4. Discomfort with pelvic exams

    Discomfort with pelvic exams is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

    Measured: 12 months

  5. Discomfort with dilator use

    Discomfort with use of the dilator is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2019
  2. Study start24 Sep 2018
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial with two arms including control arm and experimental arm
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03876860
Sponsor's protocol ID
211334
Status last verified
Oct 2023
First submitted
27 Feb 2019
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: There is no plan to make individual participant data available to other researchers

Publications

  • Brand AH, Bull CA, Cakir B. Vaginal stenosis in patients treated with radiotherapy for carcinoma of the cervix. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):288-93. doi: 10.1111/j.1525-1438.2006.00348.x.

    PubMed 16445647

  • Brand AH, Do V, Stenlake A. Can an educational intervention improve compliance with vaginal dilator use in patients treated with radiation for a gynecological malignancy? Int J Gynecol Cancer. 2012 Jun;22(5):897-904. doi: 10.1097/IGC.0b013e31824d7243.

    PubMed 22552831

  • Bruner DW, Lanciano R, Keegan M, Corn B, Martin E, Hanks GE. Vaginal stenosis and sexual function following intracavitary radiation for the treatment of cervical and endometrial carcinoma. Int J Radiat Oncol Biol Phys. 1993 Nov 15;27(4):825-30. doi: 10.1016/0360-3016(93)90455-5.

    PubMed 8244811

  • Hanlon A, Small W Jr, Strauss J, Lin LL, Hanisch L, Huang L, Bai J, Wells J, Bruner DW. Dilator Use After Vaginal Brachytherapy for Endometrial Cancer: A Randomized Feasibility and Adherence Study. Cancer Nurs. 2018 May-Jun;41(3):200-209. doi: 10.1097/NCC.0000000000000500.

    PubMed 28437283

  • Harkenrider MM, Block AM, Alektiar KM, Gaffney DK, Jones E, Klopp A, Viswanathan AN, Small W Jr. American Brachytherapy Task Group Report: Adjuvant vaginal brachytherapy for early-stage endometrial cancer: A comprehensive review. Brachytherapy. 2017 Jan-Feb;16(1):95-108. doi: 10.1016/j.brachy.2016.04.005. Epub 2016 May 31.

    PubMed 27260082

  • Jeffries SA, Robinson JW, Craighead PS, Keats MR. An effective group psychoeducational intervention for improving compliance with vaginal dilation: a randomized controlled trial. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):404-11. doi: 10.1016/j.ijrobp.2005.12.009. Epub 2006 Mar 20.

    PubMed 16542794

  • Kirchheiner K, Nout RA, Lindegaard JC, Haie-Meder C, Mahantshetty U, Segedin B, Jurgenliemk-Schulz IM, Hoskin PJ, Rai B, Dorr W, Kirisits C, Bentzen SM, Potter R, Tanderup K; EMBRACE Collaborative Group. Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study. Radiother Oncol. 2016 Jan;118(1):160-6. doi: 10.1016/j.radonc.2015.12.025. Epub 2016 Jan 9.

    PubMed 26780997

  • Kirchheiner K, Fidarova E, Nout RA, Schmid MP, Sturdza A, Wiebe E, Kranz A, Polterauer S, Potter R, Dorr W. Radiation-induced morphological changes in the vagina. Strahlenther Onkol. 2012 Nov;188(11):1010-7. doi: 10.1007/s00066-012-0222-0. Epub 2012 Sep 29.

    PubMed 23053157

  • Law E, Kelvin JF, Thom B, Riedel E, Tom A, Carter J, Alektiar KM, Goodman KA. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy. Radiother Oncol. 2015 Jul;116(1):149-55. doi: 10.1016/j.radonc.2015.06.018. Epub 2015 Jul 8.

    PubMed 26164775

  • Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev. 2014 Sep 8;2014(9):CD007291. doi: 10.1002/14651858.CD007291.pub3.

    PubMed 25198150

  • Morris L, Do V, Chard J, Brand AH. Radiation-induced vaginal stenosis: current perspectives. Int J Womens Health. 2017 May 2;9:273-279. doi: 10.2147/IJWH.S106796. eCollection 2017.

    PubMed 28496367

  • Park HS, Ratner ES, Lucarelli L, Polizzi S, Higgins SA, Damast S. Predictors of vaginal stenosis after intravaginal high-dose-rate brachytherapy for endometrial carcinoma. Brachytherapy. 2015 Jul-Aug;14(4):464-70. doi: 10.1016/j.brachy.2015.03.001. Epub 2015 Apr 14.

    PubMed 25887343

Questions about this trial

What is this clinical trial studying?

A study testing Silicone Dilator and Standard Dilator in people with Endometrial Cancer and Cervical Cancer, run by Margaret Liotta at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Danielle M Krause, MD (7082164033, dkrause@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03876860, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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