To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT

Gynecologic Cancer Clinical Trial

— SQUAL  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891470
• Other study ID #: CE3596
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 2, 2026

Study information

• Verified date: November 2023
• Source: Jules Bordet Institute
• Contact: Clémence Al Wardi, PhD
• Phone: 0032 2 541 39 81
• Email: clemence.alwardi[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: February 2, 2026
• Est. primary completion date: February 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients

• complete response on the imagery at 3 months (PET scan/MRI).

• Stades I-III

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Device:
• MonaLisa Touch device
sessions with intra-vaginal CO2 laster system
• Vaginal dilatators
Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations of the sexual function through FSFI questionnaire	Sexual QOL questionnaire	before (chemo-RT) to 15 months post (Chemo)-RT treatment
Primary	Variations of the sexual function through SHQ-22 questionnaire	Sexual QOL questionnaire	before (chemo-RT) to 15 months post (Chemo)-RT treatment
Secondary	Vaginal functional changes by means of VHI score	Objective assessement through vaginal tactus	3 months to 15 months post (Chemo)-RT treatment
Secondary	Patient complience	Percentage of patients who followed the required treatment as required.	3 months to 15 months post (Chemo)-RT treatment