Endometrial CancerVire-BrachyNCT03324958
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
A study testing Virtual reality Helmet and No Virtual Reality Helmet in people with Endometrial Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Virtual reality Helmet and No Virtual Reality Helmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Mar 2019to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Institut Gustave Roussy
Villejuif, 94805
About this study
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Virtual reality Helmet, No Virtual Reality Helmet
- Keywords
- Endometrial cancer, Brachytherapy, Virtual reality, Pain, Anxiety
- Medical subject headings
- Endometrial Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality HelmetDevice
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.
No Virtual Reality HelmetOther
The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Helmet | Experimental | 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. Receives: Device: Virtual reality Helmet |
| No Virtual Reality Helmet | Active comparator | Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice. Receives: Other: No Virtual Reality Helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain during brachytherapy applicator installations
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
Measured: 1 week
Secondary outcomes (22)
Pain during brachytherapy applicator installations, independently at each fraction
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.
Measured: 1 week
Mean anxiety during brachytherapy applicator installations
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.
Measured: 1 week
Quality of life, six to height 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).
Measured: 6 to 8 weeks after brachytherapy
Anxiety and depression, six to height 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).
Measured: 6 to 8 weeks after brachytherapy
Correlation between mean pain during brachytherapy applicator setting up and age
Correlation will potentially be established between pain during brachytherapy applicator setting up and age.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.
Correlation will potentially be established between pain during brachytherapy applicator setting up and G8 scale.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.
Correlation will potentially be established between pain during brachytherapy applicator setting up and histologic type of cancer.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.
Correlation will potentially be established between pain during brachytherapy applicator setting up and FIGO stage.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and Performance status.
Correlation will potentially be established between pain during brachytherapy applicator setting up and Performance status.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and patient weight.
Correlation will potentially be established between pain during brachytherapy applicator setting up and patient weight.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and marital status.
Correlation will potentially be established between pain during brachytherapy applicator setting up and marital status.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and socio educational status
Correlation will potentially be established between pain during brachytherapy applicator setting up and socio educational status.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.
Correlation will potentially be established between pain during brachytherapy applicator setting up and number of pregnancies.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery
Correlation will potentially be established between pain during brachytherapy applicator setting up and history of pelvic surgery.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.
Correlation will potentially be established between pain during brachytherapy applicator setting up and the number of concomitant treatment.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of cancer treatments.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed
Correlation will potentially be established between pain during brachytherapy applicator setting up and the supportive cares performed.
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme
Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy achievement
Measured: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme
Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy scheme
Measured: 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)
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).
Measured: 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).
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start26 Mar 2019
- Primary completion1 Dec 2020
- Study completion4 Mar 2021
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessment of the mean local pain during brachytherapy applicator'setting up, with and without virtual reality helmet use.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, Centre Antoine Lacassagne, Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Nicolas Magné, PhD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324958
- Sponsor's protocol ID
- 2017-0501
- Other IDs
- 2017-A01919-44
- Acronym
- Vire-Brachy
- Status last verified
- Feb 2022
- First submitted
- 20 Oct 2017
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
- ClinicalTrials.gov ID
- NCT03324958
- Acronym / sponsor ID
- Vire-Brachy / 2017-0501
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Brachytherapy, Virtual reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulties
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, Centre Antoine Lacassagne, Institut de Cancérologie de la Loire
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assessment of the mean local pain during brachytherapy applicator'setting up, with and without virtual reality helmet use.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Helmet | Experimental | Device: Virtual reality HelmetPatients 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. |
| No Virtual Reality Helmet | Active comparator | Other: No Virtual Reality HelmetPatient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality HelmetThe 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. | Device | Virtual Reality Helmet |
| No Virtual Reality HelmetThe radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice. | Other | No Virtual Reality Helmet |
Primary outcome
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
22 secondary outcomes
Pain during brachytherapy applicator installations, independently at each fraction
Time frame: 1 week
Mean anxiety during brachytherapy applicator installations
Time frame: 1 week
Quality of life, six to height weeks after brachytherapy
Time frame: 6 to 8 weeks after brachytherapy
Anxiety and depression, six to height weeks after brachytherapy
Time frame: 6 to 8 weeks after brachytherapy
Correlation between mean pain during brachytherapy applicator setting up and age
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and Performance status.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and patient weight.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and marital status.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and socio educational status
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme
Time frame: 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 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
Results and safety
The study was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Magné, PhD principal investigator
Institut de Cancérologie Lucien Neuwirth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality Helmet and No Virtual Reality Helmet in people with Endometrial Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain during brachytherapy applicator installations (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.