NCT03628092

Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvovaginal Atrophy
• Genitourinary Symptoms and Ill-Defined Conditions

Interventions

Type	Name	Description
DEVICE	CO2 Fractional Ablative Laser	Vaginal / vulval laser treatment
DEVICE	Placebo	Sham Device

Timeline

• Start date: 2018-07-24
• Primary completion: 2020-07-01
• Completion: 2021-10-01
• First posted: 2018-08-14
• Last updated: 2020-03-12

Locations

2 sites across 1 country: Australia