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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Device: MonaLisa Touch device
* Device: Vaginal dilatators


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |