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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Device: Vaginal dilatators; Device: MonaLisa Touch device

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 Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémence Al Wardi, PhD; Phone Number: 0032 2 541 39 81; Email: clemence.alwardi@hubruxelles.be
• Study Contact Backup: Name: Imane Ahrouch, MD; Email: imane.ahrouch@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vaginal Dilatators; Use of vaginal dilatators as standard of care.	Device: Vaginal dilatators; Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)
Experimental: MonaLisa Touch device; Sessions with the MonaLisa Touch device	Device: MonaLisa Touch device; sessions with intra-vaginal CO2 laster system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Investigators: Study Director: Dirk Van Gestel, Pr, MD, PhD, Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2023
• Primary Completion (Estimated): February 2, 2025
• Study Completion (Estimated): February 2, 2026

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CE3596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes