Clinical trial · Interventional
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
NCT03324958CI-TRIAL-00056391Vire-BrachyterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment difficulties
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Virtual Reality Helmet | Other | — | UNRESOLVED |
| Virtual reality Helmet | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Reality Helmet
- description
- 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.
- interventionNames
- Device: Virtual reality Helmet
- type
- ACTIVE_COMPARATOR
- label
- No Virtual Reality Helmet
- description
- Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.
- interventionNames
- Other: No Virtual Reality Helmet
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.