Clinical trial NCT03324958: VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Official title: VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Brachytherapy
Virtual reality
Pain
Anxiety
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
name: Centre Antoine Lacassagne
name: Institut de Cancérologie de la Loire
First posted: 2017-10-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessment of the mean local pain during brachytherapy applicator'setting up, with and without virtual reality helmet use.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean pain during brachytherapy applicator installations
timeFrame: 1 week
Secondary outcomes:
measure: Pain during brachytherapy applicator installations, independently at each fraction
timeFrame: 1 week
measure: Mean anxiety during brachytherapy applicator installations
timeFrame: 1 week
measure: Quality of life, six to height weeks after brachytherapy
timeFrame: 6 to 8 weeks after brachytherapy
measure: Anxiety and depression, six to height weeks after brachytherapy
timeFrame: 6 to 8 weeks after brachytherapy
measure: Correlation between mean pain during brachytherapy applicator setting up and age
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and G8 scale.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and Performance status.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and patient weight.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and marital status.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and socio educational status
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme
timeFrame: 1 week
measure: Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme
timeFrame: 1 week
measure: 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)
timeFrame: 1 week
measure: 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).
timeFrame: 1 week
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Nicolas Magné, PhD
role: PRINCIPAL_INVESTIGATOR
References: