Clinical trial · Interventional
To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MonaLisa Touch device | Device | — | UNRESOLVED |
| Vaginal dilatators | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vaginal Dilatators
- description
- Use of vaginal dilatators as standard of care.
- interventionNames
- Device: Vaginal dilatators
- type
- EXPERIMENTAL
- label
- MonaLisa Touch device
- description
- Sessions with the MonaLisa Touch device
- interventionNames
- Device: MonaLisa Touch device
Primary outcomes (2)
- measure
- Variations of the sexual function through FSFI questionnaire
- timeFrame
- before (chemo-RT) to 15 months post (Chemo)-RT treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available