An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876860
• Other study ID #: 211334
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: Loyola University
• Contact: Danielle M Krause, MD
• Phone: 7082164033
• Email: dkrause[@]lumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Constriction, Pathologic
• Endometrial Cancer
• Endometrial Neoplasms
• Radiation Toxicity
• Vaginal Stricture

Intervention

Device:
• Silicone Dilator
Addition of silicone band to standard vaginal dilator
• Standard Dilator
Standard vaginal dilator

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Margaret Liotta

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Adherence	Number of participants who use the vaginal dilator at least three times per week	12 months
Secondary	Vaginal Length	Vaginal length (in centimeters) measured using a POP-Q wooden stick	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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)	12 months
Secondary	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)	12 months