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

NCT05891470 | Unknown FDA Device

• 1 other identifier: CE3596
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (2)

• Variations of the sexual function through FSFI questionnaire

  Sexual QOL questionnaire

  before (chemo-RT) to 15 months post (Chemo)-RT treatment

• Variations of the sexual function through SHQ-22 questionnaire

  Sexual QOL questionnaire

  before (chemo-RT) to 15 months post (Chemo)-RT treatment

Secondary Outcomes (2)

• Vaginal functional changes by means of VHI score

  3 months to 15 months post (Chemo)-RT treatment

• Patient complience

  3 months to 15 months post (Chemo)-RT treatment

Study Arms (2)

Vaginal Dilatators

ACTIVE COMPARATOR

Use of vaginal dilatators as standard of care.

Device: Vaginal dilatators

MonaLisa Touch device

EXPERIMENTAL

Sessions with the MonaLisa Touch device

Device: MonaLisa Touch device

Interventions

MonaLisa Touch device DEVICE

sessions with intra-vaginal CO2 laster system

MonaLisa Touch device

Vaginal dilatators DEVICE

Home use of vaginal dilatators (at least twice a week for minimum 5 minutes)

Vaginal Dilatators

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

Study Officials

• Dirk Van Gestel, Pr, MD, PhD

  Jules Bordet Institute

  STUDY DIRECTOR

Central Study Contacts

Clémence Al Wardi, PhD

CONTACT

0032 2 541 39 81; clemence.alwardi@hubruxelles.be

Imane Ahrouch, MD

CONTACT

imane.ahrouch@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 7, 2023
• Study Start: September 1, 2023
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2026
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)