Exploring the MonaLisa Touch® System for Gynaecological Cancer Patients
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)
This study is testing if the MonaLisa Touch® laser treatment can help improve sexual health and quality of life for women with gynaecological cancer who have had pelvic radiation therapy, compared to using standard vaginal dilators.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | N/A to 80 Years |
| Sex | Female |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05891470 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the MonaLisa Touch® system, a microablative CO2 laser, in improving the quality of life for gynaecological cancer patients who have undergone pelvic (chemo-) radiotherapy. Patients will be randomly assigned to either the MonaLisa Touch® treatment or standard vaginal dilators, with assessments of sexual health and quality of life conducted at multiple intervals over a year. The study aims to address common issues such as vaginal dryness and discomfort that arise after cancer treatment, which are often overlooked. By comparing the two approaches, the trial seeks to determine if the laser treatment can provide better outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates include gynaecological cancer patients who have completed (chemo)radiotherapy and show a complete response on imaging at 3 months.
Not a fit: Patients with advanced cancer stages (M1 or Stage IV) or those who have not achieved a complete response on imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the sexual quality of life for gynaecological cancer survivors.
How similar studies have performed: While the MonaLisa Touch® has shown promise in other patient populations, this specific application for gynaecological cancer patients undergoing pelvic radiotherapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Clémence Al Wardi, PhD
- Email: clemence.alwardi@hubruxelles.be
- Phone: 0032 2 541 39 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.