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

Free University of Brussels (ULB)

Status: Enrolling

Conditions: Gynecologic Cancer

Treatments: Device: MonaLisa Touch device; Device: Vaginal dilatators

Study type: Interventional

Funder types: Other

Identifiers

NCT05891470

CE3596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Female

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Vaginal Dilatators

Active Comparator group

Description:

Use of vaginal dilatators as standard of care.

Treatment:

Device: Vaginal dilatators

MonaLisa Touch device

Experimental group

Description:

Sessions with the MonaLisa Touch device

Treatment:

Device: MonaLisa Touch device