Clinical trial NCT05891470: To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 136
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Variations of the sexual function through FSFI questionnaire
timeFrame: before (chemo-RT) to 15 months post (Chemo)-RT treatment
measure: Variations of the sexual function through SHQ-22 questionnaire
timeFrame: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Secondary outcomes:
measure: Vaginal functional changes by means of VHI score
timeFrame: 3 months to 15 months post (Chemo)-RT treatment
measure: Patient complience
timeFrame: 3 months to 15 months post (Chemo)-RT treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Jules Bordet Institute
name: Dirk Van Gestel, Pr, MD, PhD
role: STUDY_DIRECTOR
References: