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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer
• Interventions: Device: Vaginal dilatators; Device: MonaLisa Touch device

• Registration Number: NCT05891470
• Lead Sponsor: Jules Bordet Institute

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-07
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Primary Completion: 2025-02-02
• Study Completion: 2026-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
• complete response on the imagery at 3 months (PET scan/MRI).
• Stades I-III

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Dilatators	Vaginal dilatators	Use of vaginal dilatators as standard of care.
MonaLisa Touch device	MonaLisa Touch device	Sessions with the MonaLisa Touch device

Primary Outcome Measures

Name	Time	Method
Variations of the sexual function through SHQ-22 questionnaire	before (chemo-RT) to 15 months post (Chemo)-RT treatment	Sexual QOL questionnaire
Variations of the sexual function through FSFI questionnaire	before (chemo-RT) to 15 months post (Chemo)-RT treatment	Sexual QOL questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient complience	3 months to 15 months post (Chemo)-RT treatment	Percentage of patients who followed the required treatment as required.
Vaginal functional changes by means of VHI score	3 months to 15 months post (Chemo)-RT treatment	Objective assessement through vaginal tactus

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium