NCT05891470

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	MonaLisa Touch device	sessions with intra-vaginal CO2 laster system
DEVICE	Vaginal dilatators	Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-02-02
• Completion: 2026-02-02
• First posted: 2023-06-07
• Last updated: 2023-11-24

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study