Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients (LAAVA2)

Royal North Shore Hospital

Status: Unknown

Conditions: Genitourinary Symptoms and Ill-Defined Conditions; Vulvovaginal Atrophy

Treatments: Device: CO2 Fractional Ablative Laser; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03628092

LAAVA2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

CO2 Fractional Ablative Laser

Active Comparator group

Description:

3 treatments approximately 4 weeks apart with vaginal/vulval laser

Treatment:

Device: CO2 Fractional Ablative Laser

Placebo

Placebo Comparator group

Description:

3 treatments approximately 4 weeks apart with "sham" laser

Treatment:

Device: Placebo