Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
- Conditions
- Vulvovaginal AtrophyGenitourinary Symptoms and Ill-Defined Conditions
- Interventions
- Device: CO2 Fractional Ablative LaserDevice: Placebo
- Registration Number
- NCT03628092
- Lead Sponsor
- Royal North Shore Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 70
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CO2 Fractional Ablative Laser CO2 Fractional Ablative Laser 3 treatments approximately 4 weeks apart with vaginal/vulval laser Placebo Placebo 3 treatments approximately 4 weeks apart with "sham" laser
- Primary Outcome Measures
Name Time Method Vaginal dryness 12 weeks after completion of treatment 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.
- Secondary Outcome Measures
Name Time Method Other symptoms of vulvovaginal atrophy 12 weeks after completion of treatment and 12 months after active treatment Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
Clinician Assessed Changes 12 weeks after completion of treatment and 12 months after active treatment 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).
Maturation index 12 weeks after completion of treatment and 12 months after active treatment 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)
)Vaginal pH 12 weeks after completion of treatment and 12 months after active treatment Improvement in vaginal pH
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index 12 weeks after completion of treatment and 12 months after active treatment 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.
Sexual Function 12 weeks after completion of treatment and 12 months after active treatment Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
Satisfaction with treatment assessed on a Likert Scale 12 weeks after completion of treatment and 12 months after active treatment 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)
Safety of laser treatment (Side effects) 15 months Side effects reported over the duration of the study will be collected descriptively
Trial Locations
- Locations (2)
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia