To Explore the Benefits of the MonaLisa Touch® System in... | NCT05891470

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

NCT05891470

Sponsor

Jules Bordet Institute

Status

Unknown status

Last Update Posted

Nov 24, 2023Actual

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Gynecologic Cancer

Interventions

MonaLisa Touch device
Vaginal dilatators

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Feb 2, 2025Estimated

Completion Date

Feb 2, 2026Estimated

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Jun 5, 2023

First Posted Date

Jun 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Nov 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MonaLisa Touch device	Device	sessions with intra-vaginal CO2 laster system	MonaLisa Touch device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Vaginal functional changes by means of VHI score	Objective assessement through vaginal tactus	3 months to 15 months post (Chemo)-RT treatment
Patient complience	Percentage of patients who followed the required treatment as required.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clémence Al Wardi, PhD	Contact	0032 2 541 39 81		clemence.alwardi@hubruxelles.be
Imane Ahrouch, MD	Contact			imane.ahrouch@hubruxelles.be

Overall Officials

Name	Affiliation	Role
Dirk Van Gestel, Pr, MD, PhD	Jules Bordet Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jules Bordet	Recruiting	Brussels		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided