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Trial registered on ANZCTR


Registration number
ACTRN12619000865112
Ethics application status
Approved
Date submitted
6/06/2019
Date registered
18/06/2019
Date last updated
18/06/2019
Date data sharing statement initially provided
18/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of the efficacy of the MonaLisa Touch procedure for the treatment of vulvo-vaginal symptoms in patients who have a history of hormone positive breast cancer receiving endocrine therapy after surgery.
Scientific title
A randomised, wait-list control trial of the efficacy of the MonaLisa Touch procedure for the treatment of vulvo-vaginal symptoms in patients with hormone positive breast cancer receiving adjuvant endocrine therapy.
Secondary ID [1] 298334 0
None
Universal Trial Number (UTN)
U1111-1234-1584
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvo-vaginal symptoms 312980 0
Breast Cancer 313284 0
Condition category
Condition code
Reproductive Health and Childbirth 311486 311486 0 0
Menstruation and menopause
Cancer 311726 311726 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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The laser will then be activated as it is withdrawn to provide complete treatment of the vaginal walls.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
Intervention code [1] 314573 0
Treatment: Devices
Comparator / control treatment
The same procedure as in the description of the interventional group except participants assigned to this group will wait for 8 weeks until their first procedure. During this time participants in this group can continue any treatments they were already on prior to enrolment in the trial. They will then receive 3 treatments approximately 4 weeks apart
Control group
Active

Outcomes
Primary outcome [1] 320342 0
Composite Vulvovaginal symptoms as measured by VAS-VVA Scale questionnaire (Visual Analogue Scale for Vulvovaginal atrophy). This questionnaire is standardised and assesses symptoms of vaginal itching, vaginal burning, vaginal dryness, dyspareunia (painful sexual intercourse) and dysuria (painful urination).
Timepoint [1] 320342 0
Baseline, 4 weeks, 8 weeks, 20 weeks (primary endpoint), 52 weeks
Secondary outcome [1] 371275 0
Composite secondary outcome of treatment related pain as measured by 3 questions on a 10 point visual analogue scale of pain on probe insertion, pain on probe movement and pain on laser application
Timepoint [1] 371275 0
4 and 8 weeks
Secondary outcome [2] 371276 0
General treatment satisfaction as measured by a 5 point likert scale from very satisfied to very dissatisfied
Timepoint [2] 371276 0
Week 8, week 20, week 52
Secondary outcome [3] 371277 0
Quality of life as measured by a on a 7 point likert scale from very poor to excellent
Timepoint [3] 371277 0
Baseline, Week 8, Week 20 and week 52
Secondary outcome [4] 371278 0
Composite Female sexual function index as measured by the Female Sexual Function Index (FSFI)
Timepoint [4] 371278 0
Baseline, week 8, week 20, week 52
Secondary outcome [5] 371279 0
Global impression of improvement questionnaire as measured by Patients Global Impression of improvement Scale (PGI-I) standardised questionnaire. This measures the participants overall impression of their condition at that time compared to before treatment.
Timepoint [5] 371279 0
Week 20, Week 52

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by central randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be analysed using Statistical Package for the Social Sciences (SPSS) version 25 and STATA 13 statistical packages. Patient characteristics, baseline VAS-VVS, quality of life scores, and FSFI will be summarized as counts and percentages, and mean (SD), while bivariate associations will be analysed using chi-square tests, independent sample t tests and Analysis of Variance (ANOVA).
Pearson’s correlation coefficients will be used to calculate linear relationships between normally distributed continuous variables. The level for significance was set at a = .05. Intention-to-treat (ITT) analysis and per-protocol analysis will be used to analyse primary and secondary outcomes. Analysis of Covariance (ANCOVA) will be used to estimate within- and between- groups changes in the endpoints between baseline and week 8 (T1). and repeated measures ANOVA will be used to assess sustained changes in VVS symptoms over the 12-month study period.
A priori sample size calculations were performed in G*Power 3 based on the ability to detect a large effect in the primary outcome (VAS-VVS) in two groups after adjustment for two covariates (baseline (t0) VAS-VVS scores and age). From this calculation the total sample size of N = 86 is required to achieve 80% power and 95% confidence interval for detecting type 1 errors (see the G*Power 3 output below). Account for a potential loss of 20% of participants over the study period, the total sample of 104 participants will be required for this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13964 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 26734 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302875 0
Hospital
Name [1] 302875 0
Gold Coast University Hospital
Address [1] 302875 0
1 Hospital Boulevard, Southport QLD 4215
Country [1] 302875 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 302949 0
None
Name [1] 302949 0
None
Address [1] 302949 0
Country [1] 302949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303451 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303451 0
Office for Research Governance and Development
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 303451 0
Australia
Date submitted for ethics approval [1] 303451 0
13/03/2019
Approval date [1] 303451 0
22/05/2019
Ethics approval number [1] 303451 0
HREC/2019/QGC/52518

Summary
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.
Trial website


Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93698 0
A/Prof Jasotha Sanmugarajah
Address 93698 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 93698 0
Australia
Phone 93698 0
+61 07 5687 0000
Fax 93698 0
Email 93698 0
jasotha.sanmugurajah@health.qld.gov.au
Contact person for public queries
Name 93699 0
A/Prof Jasotha Sanmugarajah
Address 93699 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 93699 0
Australia
Phone 93699 0
+61 07 5687 0000
Fax 93699 0
Email 93699 0
jasotha.sanmugurajah@health.qld.gov.au
Contact person for scientific queries
Name 93700 0
A/Prof Jasotha Sanmugarajah
Address 93700 0
Gold Coast University Hospital
1 Hospital Boulevard
SOUTHPORT QLD 4215
Country 93700 0
Australia
Phone 93700 0
+61 07 5687 0000
Fax 93700 0
Email 93700 0
jasotha.sanmugurajah@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results