None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of fractional microablative carbon dioxide (CO2) laser for the treatment of vaginal atrophy in in post-menopausal women with breast cancer on aromatase inhibitors. Who is it for? You may be eligible to join this study if you are a post-menopausal female aged 18-75 years who has completed curative intent surgery and/or chemotherapy and/or radiotherapy for hormone-positive early-stage breast cancer. You will also need to be currently taking an aromatase-inhibitor for a minimum of 6 months and have reported symptoms of genitourinary syndrome of menopause (GSM) such as vaginal dryness or painful intercourse. Study details All participants in this study will receive three treatment sessions scheduled four weeks apart of fractional microablative CO2 intra-vaginal laser (MonaLisa Touch 'Trademark') MonaLisa Touch 'Trademark' is an adjustable probe inserted into the vagina that emits laser energy onto the surface of the vaginal wall to stimulate healthy tissue production and improve blood circulation. This process aims to restore the tissue to its form before you went through menopause and needed to take aromatase inhibitors. The procedure is performed by a gynaecologist (women’s health specialist) and takes approximately 10 mins. No medication or anaesthetic is required beforehand. To assess if fractional micro ablative CO2 laser is an effective in improving vaginal atrophy in women with breast cancer on aromatase inhibitors, a small tissue sampling (vaginal biopsy) under local anaesthetic and vaginal surface scraping (vaginal cytology) will be taken before and at 12-weeks after after completion of treatment for comparison. In addition, participants will be asked to complete questionnaires to assess severity of GSM symptoms and sexual functioning before and at 12-weeks after completion of treatment. Whilst fractional CO2 laser has demonstrated improvement in GSM symptoms in a general population of women, no current literature exists describing the impact of this intervention in a population of post-menopausal women with hormone-positive breast cancer on aromatase inhibitors. In this population, there are no effective long-term strategies to manage GSM.
Interventions
Fractional microablative CO2 laser (MonaLisa Touch 'Trademark') is a commercial intervention designed for the treatment of genitourinary symptoms of menopause. The product is a 22mm diameter intra-vaginal probe that emits laser energy in small 200-micron dots directly onto the vaginal epithelium in a non-continuous (pulsating) mode with the aim to improve microcirculation below the level of the vaginal mucosa resulting in formation of new collagen on atrophic tissue.
This study is a single arm
Fractional microablative CO2 laser (MonaLisa Touch 'Trademark') is a commercial intervention designed for the treatment of genitourinary symptoms of menopause. The product is a 22mm diameter intra-vaginal probe that emits laser energy in small 200-micron dots directly onto the vaginal epithelium in a non-continuous (pulsating) mode with the aim to improve microcirculation below the level of the vaginal mucosa resulting in formation of new collagen on atrophic tissue. This study is a single arm, non randomised, open label pilot study using fractional microablative CO2 intra-vaginal laser (MonaLisa Touch 'Trademark') for a total of three (10-15 minute) treatment sessions scheduled four weeks apart. A gynaecologist attached to this study trained in the MonaLisa Touch 'Trademark' technique will perform the procedure. Equipment is sterilised prior to each use. No premedication is required prior to administration unless prophylactic anti-viral medication is prescribed by the treating gynaecologist to prevent herpes reactivation in patients with a prior history of genital herpes. All subjects will be provided with written information describing in the intervention, potential side effects and pre-and post- laser instructions as outlines in the Patient Information and Consent Form.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 to 75 years, inclusive 2. Able to provide informed consent and comply with trial protocol 3. Completed curative intent surgery and/or chemotherapy and/or radiotherapy for hormone-positive early-stage breast cancer 4. Have confirmed post-menopausal status 5. Prescribed and currently taking an aromatase-inhibitor for a minimum of 6 months with or without an gonadotropin releasing hormone agonist (GnRH) 6. Have reported symptoms of GSM as defined by one of more of the following; vaginal dryness, vaginal irritation or itching, vaginal discomfort or pain and/or dyspareunia
Exclusion criteria
1. Evidence of lichen sclerosis or infection on clinical examination 2. Concurrent use of hormone replacement therapy 3, Concurrent use of topical oestrogens 4. Concurrent use of alternative/natural therapies marketed for vaginal atrophy or GSM (eg. Pro-oestrogenic compound red clover)
Outcome results
None listed