An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

NCT03876860 | Unknown FDA Device

• 1 other identifier: 211334
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Cervical Cancer; Vaginal Stricture; Radiation Toxicity

Keywords

Vaginal dilator; Vaginal stenosis

Outcome Measures

Primary Outcomes (1)

• Participant Adherence

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

  12 months

Secondary Outcomes (5)

• Vaginal Length

  12 months

• Vaginal stenosis grading scale

  12 months

• Change in female sexual function

  12 months

• Discomfort with pelvic exams

  12 months

• Discomfort with dilator use

  12 months

Study Arms (2)

Standard Dilator

ACTIVE COMPARATOR

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

Silicone Dilator

EXPERIMENTAL

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

Interventions

Silicone Dilator DEVICE

Addition of silicone band to standard vaginal dilator

Silicone Dilator

Standard Dilator DEVICE

Standard vaginal dilator

Standard Dilator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History or current presence of fistula

Sponsors & Collaborators

• Margaret Liotta: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related 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.

  PMID: 16445647 BACKGROUND

• 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.

  PMID: 22552831 BACKGROUND

• 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.

  PMID: 8244811 BACKGROUND

• 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.

  PMID: 28437283 BACKGROUND

• 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.

  PMID: 27260082 BACKGROUND

• 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.

  PMID: 16542794 BACKGROUND

• 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.

  PMID: 26780997 BACKGROUND

• 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.

  PMID: 23053157 BACKGROUND

• 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.

  PMID: 26164775 BACKGROUND

• 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.

  PMID: 25198150 BACKGROUND

• 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.

  PMID: 28496367 BACKGROUND

• 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.

  PMID: 25887343 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Wounds and Injuries

Study Officials

• Margaret R Liotta, DO

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle M Krause, MD

CONTACT

7082164033; dkrause@lumc.edu

Margaret R Liotta, DO

CONTACT

7083272104; mliotta@lumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized control trial with two arms including control arm and experimental arm

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 15, 2019
• Study Start: September 24, 2018
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)