Metastatic Prostate CancerHypProMetNCT04533958
Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy
A study testing HYPNO VR® device in people with Metastatic Prostate Cancer, run by Saint-Gregoire Private Hospital Center at 6 sites in 2 countries.
Trial summary
Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- HYPNO VR® device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 28 Sep 2020to 28 Feb 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man aged ≥ 18 years
- Histologically proven metastatic prostate adenocarcinoma,
- Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
- Patient who signed their informed consent
- Patient benefiting from social security coverage
- Patient treated and followed in the center for the duration of the study (6 months maximum).
Who cannot join
- Patient participating in another clinical trial on an experimental molecule
- Patient who received previous chemotherapy
- Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
- Patient deprived of their liberty or under guardianship
- Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France3 sites
Clinique Pasteur-Lanroze
Brest, 29200
CHP Saint-Grégoire
Saint-Grégoire, 35760
Clinique de la Côte d'Emeraude
St-Malo, 35400
Portugal3 sites
Hospital Lusiadas Amadora
Amadora, 2724-002
Hospital Lusiadas Lisboa
Lisbon, 1500-458
Hospital Lusiadas Porto
Porto, 4050-115
About this study
Official title: Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study
Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer.
The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.
Read the detailed description
After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after the 12 courses of docetaxel or premature termination of the study.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- HYPNO VR® device
- Keywords
- Virtual reality, Oncology, Chemotherapy, Anxiety
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPNO VR® deviceDevice
The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.
Before each Docetaxel infusion, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the chemotherapy program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.
After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff.
| Study group | Role | What they receive |
|---|---|---|
| HypnoVR Arm | Experimental | During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality. Receives: Device: HYPNO VR® device |
| Control Arm | No intervention | Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.
Comparison of anxiety by the State Trait Anxiety Inventory (STAI) score before and after each docetaxel infusion (i.e. 24 questionnaires) between the HypnoVR arm and the control arm. The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.
Measured: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Secondary outcomes (7)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
Comparison of nausea (Analogical Visual Scale-VAS) before and after each infusion and at the end of treatment (i.e. 24 questionnaires) between the two arms. The analogical visual scale of nausea is a 6-point scale from "no nausea" to "maximum nausea". The higher the score is, the more important nausea are.
Measured: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures
Comparison of the number of vomiting episodes (n) before and after each infusion and at the end of treatment (i.e. 24 questionnaires) between the two arms.
Measured: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state description part after the end of treatment
Comparison of the quality of life by the EQ-5D-3L questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The EQ-5D-3L questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L).
Measured: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state evaluation part after the end of treatment
Comparison of the quality of life by the EQ-5D-3L questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The EQ-5D-3L questionnaire has two components: health state description and evaluation. In the evaluation part, the respondents evaluate their overall health status using the visual analogic scale (EQ-VAS) from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable).
Measured: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the FACT-P (Functional Assessment of Cancer Therapy-Prostate) questionnaire after the end of treatment
Comparison of the quality of life by the FACT-P questionnaire before the start of treatment with Docetaxel and after the end of treatment (after 12 infusions, ie two questionnaires) between the two arms. The FACT-P is a multidimensional, self-report quality of life instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. The respondents self-rate their level of severity for each item on a 5-points scale from 0 (not at all) to 4 (very much).
Measured: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a good patient satisfaction after each infusion of Docetaxel
Evaluation of patient satisfaction in the HYPNO VR group by the patient self-questionnaire after each infusion of Docetaxel, i.e. 12 questionnaires. a level of satisfaction (on a 11-point scale from 0 to 10) of the patient will be measure for the state of relaxation, security, understanding, overall satisfaction.
Measured: For up to 6 months, every 2 weeks (after each infusion), starting on day of first infusion until day of the last twelfth infusion (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
Comparison of the proportion of antiemetic treatment prescriptions (dosage/posology stopped, added or changed) for each course between the two arms.
Measured: For up to 6 months, every 2 weeks (before each infusion), starting on day of the first infusion until the day of the last twelfth infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start28 Sep 2020
- Primary completion31 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Gregoire Private Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier ARTIGNAN, MD, Principal investigator, CHP Saint Grégoire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533958
- Sponsor's protocol ID
- 2019-A03336-51
- Acronym
- HypProMet
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2020
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy Monocentric, Comparative, Randomized, Open Study
- ClinicalTrials.gov ID
- NCT04533958
- Acronym / sponsor ID
- HypProMet / 2019-A03336-51
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Virtual reality, Oncology, Chemotherapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Saint-Gregoire Private Hospital CenterUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 1 Sep 2020 (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.
Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer.
The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.
Detailed description
After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after the 12 courses of docetaxel or premature termination of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HypnoVR Arm | Experimental | Device: HYPNO VR® deviceDuring each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality. |
| Control Arm | No intervention | –Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man aged ≥ 18 years
- Histologically proven metastatic prostate adenocarcinoma,
- Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
- Patient who signed their informed consent
- Patient benefiting from social security coverage
Key exclusion criteria (5 listed)
- Patient participating in another clinical trial on an experimental molecule
- Patient who received previous chemotherapy
- Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
- Patient deprived of their liberty or under guardianship
- Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
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 |
|---|---|---|
| HYPNO VR® deviceThe HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone. Before each Docetaxel infusion, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the chemotherapy program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality. After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff. | Device | HypnoVR Arm |
Primary outcome
Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm.
Time frame: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Comparison of anxiety by the State Trait Anxiety Inventory (STAI) score before and after each docetaxel infusion (i.e. 24 questionnaires) between the HypnoVR arm and the control arm. The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.
7 secondary outcomes
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in nausea before and after the Docetaxel cures
Time frame: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a decrease in vomiting before and after the Docetaxel cures
Time frame: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state description part after the end of treatment
Time frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the EQ-5D-3L questionnaire for the health state evaluation part after the end of treatment
Time frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by an increase in the quality of life by the FACT-P (Functional Assessment of Cancer Therapy-Prostate) questionnaire after the end of treatment
Time frame: For up to 6 months, one assessment questionnaire on day of inclusion and one assessment questionnaire at the end of study visit (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a good patient satisfaction after each infusion of Docetaxel
Time frame: For up to 6 months, every 2 weeks (after each infusion), starting on day of first infusion until day of the last twelfth infusion (month 6)
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the prescription of antiemetic treatments
Time frame: For up to 6 months, every 2 weeks (before each infusion), starting on day of the first infusion until the day of the last twelfth infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Xavier ARTIGNAN, MD principal investigator
CHP Saint Grégoire
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYPNO VR® device in people with Metastatic Prostate Cancer, run by Saint-Gregoire Private Hospital Center at 6 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Portugal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstrate a modification in anxiety after each infusion of Docetaxel in the HypnoVR arm compared to the control arm. (time frame: For up to 6 months, every 2 weeks (before and after the 12 infusions), starting on day of first infusion until day of the last twelfth infusion). 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 6 Apr 2026.