SQUAL: To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Variations of the sexual function through FSFI questionnaire [before (chemo-RT) to 15 months post (Chemo)-RT treatment]
Sexual QOL questionnaire
- Variations of the sexual function through SHQ-22 questionnaire [before (chemo-RT) to 15 months post (Chemo)-RT treatment]
Sexual QOL questionnaire
Secondary Outcome Measures
- Vaginal functional changes by means of VHI score [3 months to 15 months post (Chemo)-RT treatment]
Objective assessement through vaginal tactus
- Patient complience [3 months to 15 months post (Chemo)-RT treatment]
Percentage of patients who followed the required treatment as required.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jules Bordet Institute
Investigators
- Study Director: Dirk Van Gestel, Pr, MD, PhD, Jules Bordet Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CE3596