Clinical trial NCT03628092: Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Official title: Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulvovaginal Atrophy
Genitourinary Symptoms and Ill-Defined Conditions
Keywords: genitourinary symptoms of menopause
CO2 fractional ablative laser
Early breast cancer
Vulvovaginal atrophy
Vaginal dryness
Dyspareunia
Vaginal itch
Dysuria
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Vaginal dryness
timeFrame: 12 weeks after completion of treatment
Secondary outcomes:
measure: Other symptoms of vulvovaginal atrophy
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Maturation index
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Vaginal pH
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Clinician Assessed Changes
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Sexual Function
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Satisfaction with treatment assessed on a Likert Scale
timeFrame: 12 weeks after completion of treatment and 12 months after active treatment
measure: Safety of laser treatment (Side effects)
timeFrame: 15 months
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Antonia Pearson, BMed
role: PRINCIPAL_INVESTIGATOR
References: