None listed
Conditions
Brief summary
This study will investigate the efficacy and tolerability of the Mona Lisa Touch C02 laser procedure on vulvo-vaginal symptoms in breast cancer patients on hormonal therapy. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with hormone positive breast cancer or ductal carcinoma in situ, receiving adjuvant endocrine therapy and are experiencing vulvo-vaginal symptoms. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive 3 Mona Lisa Touch C02 laser treatments 4 weeks apart over 8 weeks. Participants in the second group will receive the same Mona Lisa Touch C02 laser treatments but 8 weeks after the first group. No treatment (outside of treatment they were already receiving prior to enrolment) will provided to participants in the first 8 weeks in this second group. Vulvo-vaginal symptoms and quality of life will be assessed using questionnaires before and after treatment. It is hoped that the results of this trial will provide evidence to determine the efficacy and safety of the procedure in patients with a history of breast cancer on hormonal treatment.
Interventions
CO2 Fractional Ablative Laser (also known known as Mona Lisa Touch Procedure)
- 3 treatments approximately 4 weeks apart performed by a qualified gynaecologist.
Topical anaesthetic (2.5g of 4% lignocaine cream) will be applied to the vulva for a minimum of 30 minutes. The treatment involves slow insertion of the vaginal probe into the vagina. The laser is set at dot power 30 watt, dwell time 1000 microseconds, dot spacing 1000 micrometres, smart stack parameter 2 and emission mode DP.
The las
CO2 Fractional Ablative Laser (also known known as Mona Lisa Touch Procedure) - 3 treatments approximately 4 weeks apart performed by a qualified gynaecologist. Topical anaesthetic (2.5g of 4% lignocaine cream) will be applied to the vulva for a minimum of 30 minutes. The treatment involves slow insertion of the vaginal probe into the vagina. The laser is set at dot power 30 watt, dwell time 1000 microseconds, dot spacing 1000 micrometres, smart stack parameter 2 and emission mode DP. The laser will then be activated as it is withdrawn to provide complete treatment of the vaginal walls. Energy is applied to the vaginal walls in a pattern pre-determined by perforations in the probe matrix which covers the laser probe, allowing for even-spacing of energy and preventing treatment of confluent areas. Furthermore, a mirror at the end of the probe is angled at 45 degrees to protect the cervix from treatment. The duration of the procedure is approximately 5 minutes. Patients will be contacted with reminder letters prior to their appointments to ensure attendance for the procedures. They will be sent reminders via SMS if available. A clinical trials nurse will audit participants details to ensure that participants are attending at correct intervals as per the trial protocol
Sponsors
Gold Coast University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre or post-menopausal women older than 18 with all of the following: • Histologically confirmed diagnosis of hormone positive (expressing >1% of either/both oestrogen or progesterone receptors) invasive breast cancer or ductal carcinoma in situ • Receiving adjuvant endocrine therapy with either an aromatase inhibitor (e.g. Anastazole, Letrozole) or selective oestrogen receptor modulator (eg. Tamoxifen) • Have symptoms consistent with VVS (vaginal dryness, vaginal burning, vaginal itching, dyspareunia or dysuria) • VVS symptoms have failed to respond to topical vaginal treatment/s and/or the patient has contraindications to topical vaginal treatment/s) • Up to date cervical screening as per Australian recommended guidelines (A normal HPV test with partial genotyping within the last five years or normal pap smear within the last two years)
Exclusion criteria
• Inability to provide informed consent • Known allergy to lignocaine cream or other topical anesthetic products • Chemotherapy within the last 6 months • Use of vaginal moisturizers or other preparations within 1 week of the study intervention • Current urinary tract infections • Active genital infections • Current genital herpes infection • Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2 • Previous vaginal prolapse surgery where mesh repair was used • Chronic disease states which may interfere with compliance to the study • Use of systemic or local hormonal treatment within 6 months • Abnormal gynecological examination • Anticoagulation with warfarin, clexane or novel anti-coagulants such as rivaroxaban (anti-platelet agents permitted) • Inherited or acquired heamophilia
Outcome results
None listed