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Vaginal Laser Therapy in Breast Cancer Survivors

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

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • Collagen [ Time Frame: 6 months ]
    Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaginal Laser Therapy in Breast Cancer Survivors
Official Title  ICMJE Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Genitourinary Syndrome of Menopause
  • Vaginal Atrophy
  • Breast Cancer
  • Dyspareunia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.)
    Intervention: Device: Microablative Fractional CO2 Laser Therapy
  • 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.
    Intervention: Device: Microablative Fractional CO2 Laser Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stavros Athanasiou, Associate Professor +306944478555 stavros.athanasiou@gmail.com
Contact: Athanasios Douskos, MD +306972845524 thanosddoc@yahoo.gr
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738605
Other Study ID Numbers  ICMJE 767/29-09-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Themos Grigoriadis, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stavros Athanasiou, Associate Proffesor National and Kapodistrian University of Athens, Greece
PRS Account National and Kapodistrian University of Athens
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP