To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT

Last updated: November 22, 2023
Sponsor: Jules Bordet Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Vaginal Cancer

Treatment

Vaginal dilatators

MonaLisa Touch device

Clinical Study ID

NCT05891470
CE3596
  • Ages < 80
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • (chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
  • complete response on the imagery at 3 months (PET scan/MRI).
  • Stades I-III

Exclusion

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

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: Vaginal dilatators
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
February 02, 2026

Study 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.

Connect with a study center

  • Institut Jules Bordet

    Brussels, 1070
    Belgium

    Active - Recruiting

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