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Trial Title:
To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT
NCT ID:
NCT05891470
Condition:
Gynecologic Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MonaLisa Touch device
Description:
sessions with intra-vaginal CO2 laster system
Arm group label:
MonaLisa Touch device
Intervention type:
Device
Intervention name:
Vaginal dilatators
Description:
Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)
Arm group label:
Vaginal Dilatators
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.
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Clemence Al Wardi, PhD
Phone:
02 5413981
Email:
clemence.alwardi@hubruxelles.be
Investigator:
Last name:
Imane Ahrouch, MD
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
February 2, 2026
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891470
