Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Study Overview
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Brief Summary
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To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.

Detailed Description
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LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive sham laser treatment (setting of close to zero) Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received sham treatment will be allowed to crossover to active treatment if they wish.

Official Title
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Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Conditions
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Vulvovaginal Atrophy, Genitourinary Symptoms and Ill-Defined Conditions

Intervention / Treatment
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* Device: CO2 Fractional Ablative Laser
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a history of early breast cancer >18 years of age At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia. Three groups of patients will qualify: Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for >6 months Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor Postmenopausal women on tamoxifen or an aromatase inhibitor Willingness to give written informed consent and willingness to comply with the study Up to date pap test / HPV (human papillomavirus) testing Exclusion Criteria: Medical contraindication to the use of fractional ablative CO2 laser Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment Use of vaginal lubricants or moisturisers 14 days prior to the study treatment Active or recent genitourinary infections (<30 days) Genital prolapse (grade III) Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts) Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO2 Fractional Ablative Laser<br>3 treatments approximately 4 weeks apart with vaginal/vulval laser | Device: CO2 Fractional Ablative Laser<br>* Vaginal / vulval laser treatment<br>* Other names: Lotus;|
| Placebo Comparator: Placebo<br>3 treatments approximately 4 weeks apart with sham laser | Device: Placebo<br>* Sham Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal dryness | Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible. | 12 weeks after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other symptoms of vulvovaginal atrophy | Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS) | 12 weeks after completion of treatment and 12 months after active treatment | 
| Maturation index | Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture) ) | 12 weeks after completion of treatment and 12 months after active treatment | 
| Vaginal pH | Improvement in vaginal pH | 12 weeks after completion of treatment and 12 months after active treatment | 
| Clinician Assessed Changes | Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours). | 12 weeks after completion of treatment and 12 months after active treatment | 
| Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index | Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life. | 12 weeks after completion of treatment and 12 months after active treatment | 
| Sexual Function | Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool | 12 weeks after completion of treatment and 12 months after active treatment | 
| Satisfaction with treatment assessed on a Likert Scale | Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree) | 12 weeks after completion of treatment and 12 months after active treatment | 
| Safety of laser treatment (Side effects) | Side effects reported over the duration of the study will be collected descriptively | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria, genitourinary symptoms of menopause