Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Fibrosis

Dilatation, Pathologic

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Quality of Life

Anal Cancer

Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy

Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

special tampon with a diameter of 28mm

patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

standard tampon with a diameter of 12-13mm

Nathalie Arians, MD

Matthias Haefner, MD

Jürgen Debus, Prof. Dr.

Adriane Hommertgen

A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \<20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \>35-49% as Grade 3 and a reduction \>/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.

The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study

during and after radiotherapy, clinical symptoms are assessed and graded

during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria

daily assessment of the clinical feasibility of daily use of a special tampon

patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use

EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life

Juergen Debus

Principal Ivestigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Constriction, Pathologic

Endometrial Neoplasms

Pathological Conditions, Anatomical

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

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

Addition of silicone band to standard vaginal dilator

Silicone Dilator

Standard Dilator

Danielle M Krause, MD

Margaret R Liotta, DO

Danielle Krause, MD

Margaret Liotta, DO

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.

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.

Randomized control trial with two arms including control arm and experimental arm

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

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

There is no plan to make individual participant data available to other researchers

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

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

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.

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.

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

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

Margaret Liotta

Assistant Professor

Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy

Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis \& assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st \& 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, \& the 2nd will be one month ± 2 weeks from last day of radiation.

Vaginal Dilator

Ethel Law, MA, RN, OCN

Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.

We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.

Study of Vaginal Dilator Use After Pelvic Radiotherapy

A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

Memorial Sloan Kettering Cancer Center

Sexual Dysfunction, Physiological

This will consist of still vaginal dilator and/or lubricant.

The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

Vaginal Renewal Program

David M Kushner, MD

This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.

In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).

Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial

Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.

The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:

0 = no pain with intercourse

1. = pain with intercourse that doesn't prevent the completion
2. = pain with intercourse requiring interruption or discontinuance
3. = pain with intercourse preventing any intercourse

Difference in Marinoff scores reported, value at 6 months minus value at baseline.

The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.

Change in vaginal length as measured from baseline to 6 months.

University of Wisconsin, Madison

Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.

Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Standard of Care

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Prior Pelvic Radiation

No Prior Pelvic Radiation

Pelvic Radiation

Ovary

Endometrium

Cervix

Vulva

Dual Primary (Ovary and Endometrium)

Primary Disease Site

The study was closed before completion due to a slowing accrual rate.

Dr. David Kushner

Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months

Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	NCT03876860	Endometrial Can... Cervical Cancer Vaginal Strictu... Radiation Toxic...	Silicone Dilato... Standard Dilato...	18 Years -	Loyola University
Study of Vaginal Dilator Use After Pelvic Radiotherapy	NCT00789893	Cervical Cancer Endometrial Can... Rectal Cancer Anal Cancer	Vaginal Dilator	21 Years - 85 Years	Memorial Sloan Kettering Cancer Center
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction	NCT01444911	Sexual Dysfunct...	Vaginal Renewal... Vaginal Dilator	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for vaginal dilator