Vaginal Laser Therapy in Breast Cancer Survivors

• ClinicalTrials.gov Identifier: NCT03738605
• Recruitment Status: Recruiting
• First Posted: November 13, 2018
• Last Update Posted: July 30, 2019
• Sponsor: National and Kapodistrian University of Athens
• Information provided by (Responsible Party): Themos Grigoriadis, National and Kapodistrian University of Athens

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Genitourinary Syndrome of Menopause; Vaginal Atrophy; Breast Cancer; Dyspareunia	Device: Microablative Fractional CO2 Laser Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
• Actual Study Start Date: December 1, 2018
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: August 2020

Arms and Interventions

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 Name: 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 Name: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Outcome Measures

Primary Outcome Measures :

1. 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness [ Time Frame: Change from baseline at 1 month post-treatment ]
   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

Secondary Outcome Measures :

1. 3 days voiding diary [ Time Frame: Change from baseline at 1 month post-treatment ]
   Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
2. Day-to Day Impact of vaginal aging questionnaire (DIVA) [ Time Frame: Change from baseline at 1 month post-treatment ]
   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
3. Patients Global Impression of Improvement [ Time Frame: At 1-month post-treatment ]
   It is a single item questionnaire assessing the impression of participants following the intervention
4. 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria [ Time Frame: Change from baseline at 1 month post-treatment ]
   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
5. King's Health Questionnaire (KHQ) [ Time Frame: Change from baseline at 1 month post-treatment ]
   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.
6. Female Sexual Function Index [ Time Frame: Change from baseline at 1 month post-treatment ]
   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
7. Vaginal Maturation Value [ Time Frame: 6 months ]
   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.
8. Vaginal Health Index Score [ Time Frame: 6 months ]
   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.
9. International Consultation on Incontinence Questionnaire Short Form [ Time Frame: 6 months ]
   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
10. Modified Sexual Quality of Life Questionnaire-Male [ Time Frame: 6 months ]
    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
11. Urogenital Distress Inventory 6 [ Time Frame: 6 months ]
    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
12. Epithelial thickness [ Time Frame: 6 months ]
    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.
13. Number of blood vessels [ Time Frame: 6 months ]
    Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed
14. Size of blood vessels [ Time Frame: 6 months ]
    Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed
15. Collagen [ Time Frame: 6 months ]
    Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Stavros Athanasiou, Associate Professor; +306944478555; stavros.athanasiou@gmail.com

Contact: Athanasios Douskos, MD; +306972845524; thanosddoc@yahoo.gr

Locations

Greece

Urogynecological Unit of Alexandra Hospital; Recruiting

Athens, Greece, 11528

Contact: Stavros Athanasiou, Prof. +306944478555 stavros.athanasiou@gmail.com

Contact: Themos Grigoriadis, Assist. Prof. +306948741306 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

Sponsors and Collaborators

National and Kapodistrian University of Athens

Investigators

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

More Information

• Responsible Party: Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens
• ClinicalTrials.gov Identifier: NCT03738605
• Other Study ID Numbers: 767/29-09-2017
• First Posted: November 13, 2018
• Last Update Posted: July 30, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Dyspareunia; Syndrome; Atrophy; Disease; Pathologic Processes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Pathological Conditions, Anatomical; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders