An interventional study of Virtual reality Helmet and No Virtual Reality Helmet in Endometrial Cancer, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Supportive care
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Among 125 studies in Endometrial Neoplasms with a site in France — 43 open to participants now, 67 under way, 14 of them phase 3. Endometrial Neoplasms · France.
Among the 125 studies in Endometrial Neoplasms with a site in France, this one is the 101st largest by enrollment of the 106 interventional ones that give a count, is one of 8 that started in 2019, is one of 17 with no phase, and was the 39th registered.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 472 are open to participants now.
Browse Endometrial Neoplasms studies →43 of the 125 studies in Endometrial Neoplasms with a site in France are open now. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in France, United States, Belgium and 3 more countries
Ages 18+
Eikon Therapeutics · Sites in France, United States, Australia and 12 more countries
Ages 18+
Genmab · Sites in France, United States, Australia and 16 more countries
Ages 18+ · Women only
GlaxoSmithKline · Sites in France, United States, Canada and 6 more countries
Ages 18+
Daiichi Sankyo · Sites in France, United States, Argentina and 12 more countries
Ages 18+ · Women only
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 358 Endometrial Neoplasms studies recruiting now, 268 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 47 · Phase 2 45 · Phase 3 21
First in 1988; this study’s year is marked. 8 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Median enrollment 265 across the 106 interventional studies, 140 across the 19 observational. Of the 50 that completed or were terminated, 9 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
70 of 125 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Centre Hospitalier Universitaire de Saint Etienne has 1 study filed under Endometrial Neoplasms — fewer than ten, so there is no comparison to draw.
15 of the studies in Endometrial Neoplasms with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04634877Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | 2026-11-20 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
| NCT06533059Alterome Therapeutics, Inc.A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors | 2026-12-29 |
| NCT05527184AbbVieFirst in Human Study of IMGN151 in Recurrent Gynaecological Cancers | 2027-02 |
Add all 15 to your calendar (.ics) → With an account.
Among the 125 studies in Endometrial Neoplasms with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.
Other: No 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.
The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.
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
Time frame: 1 week
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
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)
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).
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).
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).
Time frame: 1 week
Plan to share: No
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Ran from Mar 2019 to primary completion in Dec 2020, 20 months.
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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