Vaginal Laser Therapy in Breast Cancer Survivors

Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Vaginal Atrophy; Dyspareunia; Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: Microablative Fractional CO2 Laser Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Recruiting
    • Urogynecological Unit of Alexandra Hospital
    • Contact: Themos Grigoriadis, Assist. Prof.; Phone Number: +306948741306; Email: tgregos@yahoo.com
    • Principal Investigator: Stavros Athanasiou, Associate Professor
    • Sub-Investigator: Themos Grigoriadis, Assistant Proffesor
    • Sub-Investigator: Eleni Pitsouni, MD,MSc
    • Principal Investigator: Athanasios Douskos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Group; 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.)	Device: Microablative Fractional CO2 Laser Therapy; 5 laser therapies intravaginally administered will be applied at monthly intervals.; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Placebo Comparator: Placebo; 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.	Device: Microablative Fractional CO2 Laser Therapy; 5 laser therapies intravaginally administered will be applied at monthly intervals.; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness	It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness	Change from baseline at 1 month post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 days voiding diary	Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake	Change from baseline at 1 month post-treatment
Day-to Day Impact of vaginal aging questionnaire (DIVA)	It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact	Change from baseline at 1 month post-treatment
Patients Global Impression of Improvement	It is a single item questionnaire assessing the impression of participants following the intervention	At 1-month post-treatment
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria	It is a straight line with 2 endpoints "0" and "10". Zero defines "no symptom (itching, burning and dysuria) at all" , while 10 "symptom (itching, burning and dysuria) as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of itching, burning and dysuria	Change from baseline at 1 month post-treatment
King's Health Questionnaire (KHQ)	It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.	Change from baseline at 1 month post-treatment
Female Sexual Function Index	It is a questionnaire defining women's sexual function. It includes 6 domains: desire, arousal, orgasm, lubrication, satisfaction and pain. The answer of each Question in each domain are multiplied by a certain factor. Total score is calculated by summing the scores of the all domains with a minimum value of 2 and a maximum of 36. The highest the total score the better is the sexual functioning. Total score above 26.55 defines normal sexual function	Change from baseline at 1 month post-treatment
Vaginal Maturation Value	It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.	6 months
Vaginal Health Index Score	It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.	6 months
International Consultation on Incontinence Questionnaire Short Form	it is a questionnaire with 4 questions assessing the amount of leakage, frequency and type of urinary incontinence. Total score is calculated by summing the 3 out of the 4 questions. Higher scores indicate worst urinary incontinence	6 months
Modified Sexual Quality of Life Questionnaire-Male	It includes 12 questions assessing the quality of life and sexual satisfaction of the male partner. Each answer may receive values from 1 to 5. The higher the scores the better subjective evaluation of sexual quality of life	6 months
Urogenital Distress Inventory 6	It is a condition specific questionnaire containing 6 questions. The answers of questions assesses the presence of symptoms and the degree of bother on a 4-point scale ("not at all", "a little bit", "moderately" and "greatly" applying to 0, 1, 2 and 3, respectively). Total score is calculated by summing the score of each question. The higher the total score the highest is the symptom bother	6 months
Epithelial thickness	Biopsies will be obtained from the lateral vaginal wall. Epithelial thickness (in μ) will be measured by a vertical line between basal layer cells and superficial layers.	6 months
Number of blood vessels	Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed	6 months
Size of blood vessels	Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed	6 months
Collagen	Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.	6 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Study Director: Stavros Athanasiou, Associate Proffesor, National and Kapodistrian University of Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 28, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease; Breast Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Syndrome; Breast Neoplasms; Dyspareunia
• Other Study ID Numbers: 767/29-09-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No