MedDataX Logo

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

NCT ID: NCT05891470

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaginal Dilatators

Use of vaginal dilatators as standard of care.

Group Type ACTIVE_COMPARATOR

Vaginal dilatators

Intervention Type DEVICE

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

MonaLisa Touch device

Sessions with the MonaLisa Touch device

Group Type EXPERIMENTAL

MonaLisa Touch device

Intervention Type DEVICE

sessions with intra-vaginal CO2 laster system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MonaLisa Touch device

sessions with intra-vaginal CO2 laster system

Intervention Type DEVICE

Vaginal dilatators

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clémence Al Wardi

Pr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dirk Van Gestel, Pr, MD, PhD

Role: STUDY_DIRECTOR

Jules Bordet Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Clémence Al Wardi, PhD

Role: CONTACT

[email protected]
0032 2 541 39 81

Imane Ahrouch, MD

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Clemence Al Wardi, PhD

Role: primary

[email protected]
02 5413981

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE3596

Identifier Type: -

Identifier Source: org_study_id