Status:
TERMINATED
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
Centre Antoine Lacassagne
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 anxiet...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03324958
Start Date
March 26 2019
End Date
March 4 2021
Last Update
February 8 2022
Active Locations (2)
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1
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
2
Institut Gustave Roussy
Villejuif, France, 94805