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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Maximum Age: 80
Healthy Volunteers: f
View:

• (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients

• complete response on the imagery at 3 months (PET scan/MRI).

• Stades I-III

Locations
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Brussels
Contact Information
Primary
Clémence Al Wardi, PhD
clemence.alwardi@hubruxelles.be
0032 2 541 39 81
Backup
Imane Ahrouch, MD
imane.ahrouch@hubruxelles.be
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-02-02
Participants
Target number of participants: 136
Treatments
Active_comparator: Vaginal Dilatators
Use of vaginal dilatators as standard of care.
Experimental: MonaLisa Touch device
Sessions with the MonaLisa Touch device
Related Therapeutic Areas
Sponsors
Leads: Jules Bordet Institute

This content was sourced from clinicaltrials.gov

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