Gynecologic CancerSQUALNCT05891470
To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT
A study testing MonaLisa Touch device and Vaginal dilatators in people with Gynecologic Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The increasing survival rate of gynaecological cancer patients highlights the need to improve their Quality of Life (QoL) after treatment. Among all QoL factors, sexuality is unfortunately often neglected, especially vaginal dryness and fibrosis/stenosis. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- MonaLisa Touch device and Vaginal dilatators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 2 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
- complete response on the imagery at 3 months (PET scan/MRI).
- Stades I-III
Who cannot join
- M1
- Stade IV
- No complete response under imagery at 3months
- Relapse of gynaecological cancer
- Active gynaecological infection
- Pelvic organ prolapse more than stage II
- Local vaginal hormone therapy within 6 weeks prior to enrolment
Trial locations and contacts
1 site in 1 country.
Imane Ahrouch, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Clemence Al Wardi, PhD, 02 5413981, clemence.alwardi@hubruxelles.be
Imane Ahrouch, MD
About this study
Official title: A Randomized Phase II Study to Explore the Benefits of the MonaLisa Touch® System in the Improvement of the Sexual QUAlity of Life in Gynaecological Cancer Patients Treated by (Chemo)-Radiotherapy.(SQUAL)
The increasing survival rate of gynaecological cancer patients highlights the need to improve their Quality of Life (QoL) after treatment. Among all QoL factors, sexuality is unfortunately often neglected, especially vaginal dryness and fibrosis/stenosis. Currently, the latter is standardly treated by vaginal dilators, which may induce pain and discomfort (1). A new possibility, already used in some centers, is the MonaLisa Touch® system, a microablative CO2 laser (2). Its efficiency to improve sexual QoL has already been demonstrated in breast cancer patients treated with chemotherapy and/or hormonotherapy and in menopausal women (3). Unfortunately, almost no study have been conducted yet for patients undergoing radiotherapy to the pelvic area to prevent vaginal morbidity. Our randomised study will explore the benefits of the MonaLisa Touch® device for the prevention of sexual adverse events induced by pelvic (chemo-) radiotherapy for pelvic cancers.
Read the detailed description
Patients will be randomly (1:1) assigned to the dilators (standard of care) or MonaLisa Touch® system (2 arms). Patients will be stratified for endometrial or cervix cancer, radiotherapy dose and techniques, menopausal status, tumor stage, chemotherapy or not, surgery or not. Patients will begin the Mona Lisa at 3 months, once per month during 6 months while the follow-up assessment will continue until 12M after end of RT treatment. Patients randomized in dilator arm will also begin 3 months post end of RT and will use them twice every 2 weeks for 12M (as standard of care).
Questionnaires (FSFI- Female Sexual Function Index [10], SHQ-22) and VHI (Vaginal Health Index [11]) will be performed before treatment, at 3, 6, 9, 12 and 15M. Partners will also be asked to fill the sexual quality of life questionnaire EORTC SHQ-22 before and after treatment.
- Conditions
- Gynecologic Cancer
- Being tested
- MonaLisa Touch device, Vaginal dilatators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonaLisa Touch deviceDevice
sessions with intra-vaginal CO2 laster system
Vaginal dilatatorsDevice
Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Dilatators | Active comparator | Use of vaginal dilatators as standard of care. Receives: Device: Vaginal dilatators |
| MonaLisa Touch device | Experimental | Sessions with the MonaLisa Touch device Receives: Device: MonaLisa Touch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations of the sexual function through FSFI questionnaire
Sexual QOL questionnaire
Measured: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Variations of the sexual function through SHQ-22 questionnaire
Sexual QOL questionnaire
Measured: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Secondary outcomes (2)
Vaginal functional changes by means of VHI score
Objective assessement through vaginal tactus
Measured: 3 months to 15 months post (Chemo)-RT treatment
Patient complience
Percentage of patients who followed the required treatment as required.
Measured: 3 months to 15 months post (Chemo)-RT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Sep 2023
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clémence Al Wardi, Jules Bordet Institute
- Investigators
- Dirk Van Gestel, Pr, MD, PhD, Study director, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891470
- Sponsor's protocol ID
- CE3596
- Acronym
- SQUAL
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study to Explore the Benefits of the MonaLisa Touch® System in the Improvement of the Sexual QUAlity of Life in Gynaecological Cancer Patients Treated by (Chemo)-Radiotherapy.(SQUAL)
- ClinicalTrials.gov ID
- NCT05891470
- Acronym / sponsor ID
- SQUAL / CE3596
- Conditions
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 7 Jun 2023 (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.
The increasing survival rate of gynaecological cancer patients highlights the need to improve their Quality of Life (QoL) after treatment. Among all QoL factors, sexuality is unfortunately often neglected, especially vaginal dryness and fibrosis/stenosis. Currently, the latter is standardly treated by vaginal dilators, which may induce pain and discomfort (1). A new possibility, already used in some centers, is the MonaLisa Touch® system, a microablative CO2 laser (2). Its efficiency to improve sexual QoL has already been demonstrated in breast cancer patients treated with chemotherapy and/or hormonotherapy and in menopausal women (3). Unfortunately, almost no study have been conducted yet for patients undergoing radiotherapy to the pelvic area to prevent vaginal morbidity. Our randomised study will explore the benefits of the MonaLisa Touch® device for the prevention of sexual adverse events induced by pelvic (chemo-) radiotherapy for pelvic cancers.
Detailed description
Patients will be randomly (1:1) assigned to the dilators (standard of care) or MonaLisa Touch® system (2 arms). Patients will be stratified for endometrial or cervix cancer, radiotherapy dose and techniques, menopausal status, tumor stage, chemotherapy or not, surgery or not. Patients will begin the Mona Lisa at 3 months, once per month during 6 months while the follow-up assessment will continue until 12M after end of RT treatment. Patients randomized in dilator arm will also begin 3 months post end of RT and will use them twice every 2 weeks for 12M (as standard of care).
Questionnaires (FSFI- Female Sexual Function Index [10], SHQ-22) and VHI (Vaginal Health Index [11]) will be performed before treatment, at 3, 6, 9, 12 and 15M. Partners will also be asked to fill the sexual quality of life questionnaire EORTC SHQ-22 before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Dilatators | Active comparator | Device: Vaginal dilatatorsUse of vaginal dilatators as standard of care. |
| MonaLisa Touch device | Experimental | Device: MonaLisa Touch deviceSessions with the MonaLisa Touch device |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
- complete response on the imagery at 3 months (PET scan/MRI).
- Stades I-III
Key exclusion criteria (7 listed)
- M1
- Stade IV
- No complete response under imagery at 3months
- Relapse of gynaecological cancer
- Active gynaecological infection
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 |
|---|---|---|
| MonaLisa Touch devicesessions with intra-vaginal CO2 laster system | Device | MonaLisa Touch device |
| Vaginal dilatatorsHome use of vaginal dilatators (at least twice a week for minimum 5 minutes) | Device | Vaginal Dilatators |
Primary outcome
Variations of the sexual function through FSFI questionnaire
Time frame: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Sexual QOL questionnaire
Variations of the sexual function through SHQ-22 questionnaire
Time frame: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Sexual QOL questionnaire
2 secondary outcomes
Vaginal functional changes by means of VHI score
Time frame: 3 months to 15 months post (Chemo)-RT treatment
Patient complience
Time frame: 3 months to 15 months post (Chemo)-RT treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- 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.
Imane Ahrouch, MD contact
Dirk Van Gestel, Pr, MD, PhD study director
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MonaLisa Touch device and Vaginal dilatators in people with Gynecologic Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clémence Al Wardi, PhD (0032 2 541 39 81, clemence.alwardi@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations of the sexual function through FSFI questionnaire (time frame: before (chemo-RT) to 15 months post (Chemo)-RT treatment). The study lists 2 primary outcomes in all. 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 24 Nov 2023.