To hear about similar clinical trials, please enter your email below
Trial Title:
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
NCT ID:
NCT05713435
Condition:
Genitourinary Syndrome of Menopause
Conditions: Official terms:
Syndrome
Conditions: Keywords:
genitourinary syndrome of menopause
intravaginal laser
breast cancer
aromatase inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
3 parallel arms of equal size, participants can cross over after 3 initial treatments
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
participant and outcome assessor are blinded
Intervention:
Intervention type:
Device
Intervention name:
intravaginal laser
Description:
application of intravaginal laser
Arm group label:
Fotona Smooth erbium:YAG laser
Arm group label:
Mona Lisa Touch CO2 laser
Arm group label:
sham treatment
Summary:
To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG
laser and sham application in alleviating genitourinary symptoms in patients receiving an
aromatase inhibitor as adjuvant treatment of breast cancer
Detailed description:
The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2
LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser
(Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal
applications for treatment of vaginal dryness as the leading symptom in breast cancer
patients with iatrogenic menopause and treated with an AI.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Recruited participants will meet all of these criteria:
- a history of breast cancer
- premenopausal at diagnosis of breast cancer
- using AI as an adjuvant treatment
- moderate to severe symptoms of GSM (VAS ≥ 4/10)
- currently menopausal, which can be either biochemical menopause as confirmed after
chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of
the trial)
Exclusion Criteria:
- Not willing to abstain from vaginal intercourse for 1 week following laser therapy
- Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
- Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
- Acute urinary or genital tract infections
- A history of genital fistula, a thin rectovaginal septum as determined by the
investigator, or history of fourth degree laceration
- Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
- Previous vaginal mesh implantation
- Abnormal result in the last cervical smear (maximum 36 month before enrollment)
- Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to
the measurement of the primary outcome (6 months after inclusion, 3 months after
last laser)
- Vaginal stenosis that does not allow the placement of the laser probe
- Any condition that could interfere with study compliance
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Susanne Housmans, MD
Phone:
+3216332211
Email:
susanne.housmans@uzleuven.be
Contact backup:
Last name:
Jan Deprest, PhD
Phone:
+3216332211
Email:
jan.deprest@uzleuven.be
Start date:
December 27, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713435
