An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

NCT ID: NCT03876860

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2024-04-01

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.

Conditions

Endometrial Cancer; Cervical Cancer; Vaginal Stricture; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard Dilator

Intervention Type: DEVICE

Standard vaginal dilator

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

Group Type: EXPERIMENTAL

Silicone Dilator

Intervention Type: DEVICE

Addition of silicone band to standard vaginal dilator

Interventions

Silicone Dilator

Addition of silicone band to standard vaginal dilator

Intervention Type: DEVICE

Standard Dilator

Standard vaginal dilator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Margaret Liotta

OTHER

Sponsor Role: lead

Responsible Party

Margaret Liotta

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margaret R Liotta, DO

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danielle M Krause, MD

Role: CONTACT

dkrause@lumc.edu

7082164033

Margaret R Liotta, DO

Role: CONTACT

mliotta@lumc.edu

7083272104

Facility Contacts

Danielle Krause, MD

Role: primary

dkrause@lumc.edu

708-216-4033

Margaret Liotta, DO

Role: backup

mliotta@lumc.edu

7083272104

References

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.

Reference Type: BACKGROUND

PMID: 16445647 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22552831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8244811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28437283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27260082 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16542794 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26780997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23053157 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26164775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25198150 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28496367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25887343 (View on PubMed)

Other Identifiers

211334

Identifier Type: -

Identifier Source: org_study_id