Vaginal Laser Therapy in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03738605
• Other study ID #: 767/29-09-2017
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 2020

Study information

• Verified date: July 2019
• Source: National and Kapodistrian University of Athens
• Contact: Stavros Athanasiou, Associate Professor
• Phone: +306944478555
• Email: stavros.athanasiou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Breast Cancer
• Breast Neoplasms
• Dyspareunia
• Genitourinary Syndrome of Menopause
• Syndrome
• Vaginal Atrophy

Intervention

Device:
• Microablative Fractional CO2 Laser Therapy
5 laser therapies intravaginally administered will be applied at monthly intervals.

Locations

Country	Name	City	State
Greece	Urogynecological Unit of Alexandra Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patients Global Impression of Improvement	It is a single item questionnaire assessing the impression of participants following the intervention	At 1-month post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of blood vessels	Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed	6 months
Secondary	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
Secondary	Collagen	Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.	6 months