Laser Therapy Following Radiotherapy for Gynecological Cancer

The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Study Overview

• Status: Unknown
• Conditions: Vaginal Dryness; Dyspareunia; Gynecological Cancer; Pelvic Radiotherapy
• Intervention / Treatment: Device: Microablative Fractional CO2 Laser Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Recruiting
    • Urogynecological Unit of Alexandra Hospital
    • Contact: Stavros Athanasiou, Associate professor; Phone Number: +306944478555; Email: stavros.athanasiou@gmail.com
    • Sub-Investigator: Eleni Pitsouni, MD,MSc
    • Contact: Themos Grigoriadis, Assistant Professor; Phone Number: +306948741306; Email: tgregos@yahoo.com
    • Principal Investigator: Stavros Athanasiou, Prof.
    • Sub-Investigator: Themos Grigoriadis, Assist. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• History of gynecological cancer treated with pelvic radiotherapy
• last radiotherapy >1 year
• women sexually active or willing to resume sexual activity
• symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse

Exclusion Criteria:

• Relapse of gynecological cancer
• prolapse stage >1
• active genital infection (i.e herpes, vaginitis)
• underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)

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
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
Experimental: Laser; 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

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
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)	It includes 4 functional scales (body image, sexual activity, sexual enjoyment, sexual/vaginal functioning) with 9 items and 5 symptoms scales (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms and sexual worry) with 15 items. Each item range from 1 to 4. Higher scores in sexual activity and sexual enjoyment indicate better functioning, while higher scores in all other domains indicate higher impact of cervical cancer	Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)	It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.	Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) 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 King's Health Questionnaire at 1-month post-treatment
Female Sexual Function Index	It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36	Change from baseline Female Sexual Function Index 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.	Change from baseline Vaginal Maturation Value at 1-month post-treatment
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.	Change from baseline Vaginal Health Index Score at 1-month post-treatment
Partner Performance Questionnaire	It evaluates aspects of sexual satisfaction of cancer survivors partners	Change from baseline Partner Performance Questionnaire at 1-month post-treatment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 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; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia
• Other Study ID Numbers: 143/21-03-2018

Drug and device information, study documents

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