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Vaginal Laser Therapy in Breast Cancer Survivors

Primary Purpose

Genitourinary Syndrome of Menopause, Vaginal Atrophy, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Microablative Fractional CO2 Laser Therapy
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genitourinary Syndrome of Menopause

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Urogynecological Unit of Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser Group

Placebo

Arm 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.)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3 days voiding diary
Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
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
Patients Global Impression of Improvement
It is a single item questionnaire assessing the impression of participants following the intervention
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
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.
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
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.
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.
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
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
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
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.
Number of blood vessels
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed
Size of blood vessels
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed
Collagen
Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.

Full Information

First Posted
November 6, 2018
Last Updated
July 28, 2019
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03738605
Brief Title
Vaginal Laser Therapy in Breast Cancer Survivors
Official Title
Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause, Vaginal Atrophy, Breast Cancer, Dyspareunia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser Group
Arm Type
Experimental
Arm 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.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Microablative Fractional CO2 Laser Therapy
Other Intervention Name(s)
SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Intervention Description
5 laser therapies intravaginally administered will be applied at monthly intervals.
Primary Outcome Measure Information:
Title
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
Description
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
Time Frame
Change from baseline at 1 month post-treatment
Secondary Outcome Measure Information:
Title
3 days voiding diary
Description
Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
Time Frame
Change from baseline at 1 month post-treatment
Title
Day-to Day Impact of vaginal aging questionnaire (DIVA)
Description
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
Time Frame
Change from baseline at 1 month post-treatment
Title
Patients Global Impression of Improvement
Description
It is a single item questionnaire assessing the impression of participants following the intervention
Time Frame
At 1-month post-treatment
Title
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
Description
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
Time Frame
Change from baseline at 1 month post-treatment
Title
King's Health Questionnaire (KHQ)
Description
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.
Time Frame
Change from baseline at 1 month post-treatment
Title
Female Sexual Function Index
Description
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
Time Frame
Change from baseline at 1 month post-treatment
Title
Vaginal Maturation Value
Description
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.
Time Frame
6 months
Title
Vaginal Health Index Score
Description
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.
Time Frame
6 months
Title
International Consultation on Incontinence Questionnaire Short Form
Description
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
Time Frame
6 months
Title
Modified Sexual Quality of Life Questionnaire-Male
Description
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
Time Frame
6 months
Title
Urogenital Distress Inventory 6
Description
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
Time Frame
6 months
Title
Epithelial thickness
Description
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.
Time Frame
6 months
Title
Number of blood vessels
Description
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed
Time Frame
6 months
Title
Size of blood vessels
Description
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed
Time Frame
6 months
Title
Collagen
Description
Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stavros Athanasiou, Associate Professor
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Douskos, MD
Phone
+306972845524
Email
thanosddoc@yahoo.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate Proffesor
Organizational Affiliation
National and Kapodistrian University of Athens, Greece
Official's Role
Study Director
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Prof.
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, Assist. Prof.
Phone
+306948741306
Email
tgregos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate Professor
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, Assistant Proffesor
First Name & Middle Initial & Last Name & Degree
Eleni Pitsouni, MD,MSc
First Name & Middle Initial & Last Name & Degree
Athanasios Douskos, MD

12. IPD Sharing Statement

Learn more about this trial

Vaginal Laser Therapy in Breast Cancer Survivors

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