VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients. (Vire-Brachy)

February 7, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne
This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endometrial cancer is one of the most common gynaecological cancers among women in the developed countries. After a curative surgical treatment, many relapses occur in the vaginal cuff. The PORTEC-2 trial has demonstrated a similar reduction in local relapses of intermediate- to high-risk endometrial cancer with vaginal cuff brachytherapy (VCB) than with external beam radiotherapy (EBRT). However, VCB induced less late toxicities. VCB is therefore indicated after surgery for intermediate- to high-risk endometrial cancer. VCB is also recommended after radiation therapy, for patients with stage II or III type 1 endometrial cancers according to the International Federation of Gynaecology and Obstetrics classification (FIGO), and for all patients with histological type 2 endometrial cancers.

If the late tolerance of VCB is correct, the acute tolerance remains limited, and is mainly characterized by local pain and anxiety) Virtual reality appears to be a promising tool to enhance treatment cancer tolerance, offering a safe and entertaining environment. By the way, the use of virtual reality could limit physical and psychical discomfort induced by VCB.

This randomized phase III multicenter trial aims to assess the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain (primary endpoint), and in terms of anxiety (secondary endpoint). Randomization will define which patient will wear a virtual reality helmet. Stratification will be performed according to the following criteria: vaginal molded applicator versus cylinder, two applications versus four; <70 years versus> 70 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie Lucien Neuwirth
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients over 18 years old.
  • Patients with endometrial cancer, with histological type I and II, regardless of the degree of differentiation.
  • Patients with stage I, II or III endometrial cancer according to the FIGO classification.
  • Patients treated with high-dose-rate vaginal cuff brachytherapy, with curative intent.
  • Patients affiliated or entitled to a social security scheme.
  • Patients who received information about the study and co-signed with the investigator the consent to participate at the study.

Exclusion Criteria:

  • Patients with stage IV endometrial cancer according to FIGO classification.
  • Patients presenting recurrence of endometrial cancer.
  • Pregnant or nursing women.
  • Patients under protection of justice or unable to give consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Virtual Reality Helmet
Patients will use a virtual reality helmet during brachytherapy applicator's setting up. The use of virtual reality helmet has already been assessed during oncologic treatments, and seems to reduce pain and anxiety. The use of virtual reality helmet has never been assessed to reduce the pain or anxiety associated with brachytherapy applicators' setting up.
Device: Virtual reality Helmet
The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.
ACTIVE_COMPARATOR: No Virtual Reality Helmet
Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.
Other: No Virtual Reality Helmet
The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean pain during brachytherapy applicator installations
Time Frame: 1 week
Pain assessment will be done with visual analogue scale pain (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt), before and after brachytherapy applicator setting up
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain during brachytherapy applicator installations, independently at each fraction
Time Frame: 1 week
Pain assessment will be done with visual analogue scale pain (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt), before and after brachytherapy applicator setting up.
1 week
Mean anxiety during brachytherapy applicator installations
Time Frame: 1 week
Anxiety assessment will be done with visual analogue scale (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt) anxiety, before and after brachytherapy applicator setting up, and with Hamilton scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety) before brachytherapy applicator setting up.
1 week
Quality of life, six to height weeks after brachytherapy
Time Frame: 6 to 8 weeks after brachytherapy
Quality of life assessment will be done with the the endometrial cancer (EC)-specific Quality of Life module of the European Organization for Research and Treatment of Cancer (EORTC QLQ-EN24).
6 to 8 weeks after brachytherapy
Anxiety and depression, six to height weeks after brachytherapy
Time Frame: 6 to 8 weeks after brachytherapy
Anxiety and depression will be assessed six to height weeks after brachytherapy with the Hamilton Anxiety and Depression scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety).
6 to 8 weeks after brachytherapy
Correlation between mean pain during brachytherapy applicator setting up and age
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and age.
1 week
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and G8 scale.
1 week
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and histologic type of cancer.
1 week
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and FIGO stage.
1 week
Correlation between mean pain during brachytherapy applicator setting up and Performance status.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and Performance status.
1 week
Correlation between mean pain during brachytherapy applicator setting up and patient weight.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and patient weight.
1 week
Correlation between mean pain during brachytherapy applicator setting up and marital status.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and marital status.
1 week
Correlation between mean pain during brachytherapy applicator setting up and socio educational status
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and socio educational status.
1 week
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and number of pregnancies.
1 week
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and history of pelvic surgery.
1 week
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the number of concomitant treatment.
1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of concomitant treatment.
1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of cancer treatments.
1 week
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the supportive cares performed.
1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy achievement
1 week
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy scheme
1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4)
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).
1 week
Correlation between mean pain during brachytherapy applicator setting up and the toxicities of previous brachytherapy fractions (describe according to the Common Terminology Criteria for Adverse Events 4.4).
Time Frame: 1 week
Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Cancérologie de la Loire
Gustave Roussy, Cancer Campus, Grand Paris
Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0501
  • 2017-A01919-44 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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