Vaginal Laser Therapy in Breast Cancer Survivors

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Breast Cancer; Dyspareunia; Vaginal Atrophy; Genitourinary Syndrome of Menopause

Treatments: Device: Microablative Fractional CO2 Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03738605

767/29-09-2017

Details and patient eligibility

About

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

Enrollment: 50 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• breast cancer history
• dyspareunia
• dryness

Exclusion criteria

• Active genital infection (i.e herpes, vaginitis)
• Prolapse stage >=2
• Underlying pathologies that could interfere with the protocol compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups, including a placebo group

Laser Group

Experimental group

Description:

Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)

Treatment:

Device: Microablative Fractional CO2 Laser Therapy

Placebo

Placebo Comparator group

Description:

Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Treatment:

Device: Microablative Fractional CO2 Laser Therapy