Laser Therapy Following Radiotherapy for Gynecological Cancer

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

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

Conditions
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Pelvic Radiotherapy, Gynecological Cancer, Dyspareunia, Vaginal Dryness

Intervention / Treatment
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* Device: Microablative Fractional CO2 Laser Therapy


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>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<br>* 5 laser therapies intravaginally administered will be applied at monthly intervals.<br>* Other names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy;|
| Placebo Comparator: Placebo<br>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<br>* 5 laser therapies intravaginally administered will be applied at monthly intervals.<br>* Other names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy;|

What is the study measuring?
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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 | 
| 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 | 
| Patients Global Impression of Improvement | It is a single item questionnaire assessing the impression of participants following the intervention | 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 |