Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000287336p
Ethics application status
Submitted, not yet approved
Date submitted
16/02/2017
Date registered
24/02/2017
Date last updated
24/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of vaginal atrophy using fractional micro ablative carbon dioxide (CO2) laser in post-menopausal women with breast cancer on aromatase inhibitors: a pilot study
Scientific title
Treatment of vaginal atrophy using fractional microablative CO2 laser in post-menopausal women with breast cancer on aromatase inhibitors: a pilot study
Secondary ID [1] 291203 0
None
Universal Trial Number (UTN)
U1111-1193-1838
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 302112 0
Genitourinary syndrome of Menopause 302113 0
Vulval-vaginal atrophy 302114 0
Condition category
Condition code
Cancer 301730 301730 0 0
Breast
Renal and Urogenital 301731 301731 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 301732 301732 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297209 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301127 0
Severity of genitourinary syndrome of menopause (GSM) symptoms measured by the Urogenital Atrophy Questionnaire (UAQ) score
Timepoint [1] 301127 0
12 weeks post completion of treatment
Primary outcome [2] 301128 0
Severity of GSM symptoms measured by the Vaginal Health Index Score (VHIS).
Timepoint [2] 301128 0
12 weeks post completion of treatment
Secondary outcome [1] 331798 0
Cytological change in vaginal atrophy measured by the Vaginal Epithelial Maturation Index (VEMI)
Timepoint [1] 331798 0
12 weeks post completion of treatment
Secondary outcome [2] 331799 0
Histological changes in vaginal atrophy assessed by central pathology review
Timepoint [2] 331799 0
12 weeks post completion of treatment
Secondary outcome [3] 331800 0
Sexual functioning assessed by the Female Sexual Function Index (FSFI)
Timepoint [3] 331800 0
12 weeks post completion of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Non randomised single arm, open label pilot study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This pilot study aims to enroll 36 women over a period of 18 months. The study is designed to detect a change of 30% with a 95% confidence interval +/- 11% in the proportion of women reporting ‘none’ or ‘some’ symptoms of GSM on the Urogenital Atrophy Questionnaire, a patient-reported questionnaire.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7502 0
Cabrini Brighton - Brighton
Recruitment hospital [2] 7503 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 15328 0
3186 - Brighton
Recruitment postcode(s) [2] 15329 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 295648 0
Other Collaborative groups
Name [1] 295648 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 295648 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Breast Cancer Trials Group
Address
Australia & New Zealand Breast Cancer Trials Group
PO Box 283
THE JUNCTION NSW 2291
Australia
Country
Australia
Secondary sponsor category [1] 294487 0
None
Name [1] 294487 0
None
Address [1] 294487 0
None
Country [1] 294487 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296967 0
Cabrini Human Research Ethics Committee (CHREC)
Ethics committee address [1] 296967 0
154 Wattletree Road Malvern VIC 3144
Ethics committee country [1] 296967 0
Australia
Date submitted for ethics approval [1] 296967 0
01/12/2016
Approval date [1] 296967 0
Ethics approval number [1] 296967 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72566 0
Dr Yoland Antill
Address 72566 0
Oncology Clinics Victoria, Cabrini Health, 183 Wattletree Rd. Malvern VIC 3144
Country 72566 0
Australia
Phone 72566 0
+ 61 3 9509 6988
Fax 72566 0
Email 72566 0
[email protected]
Contact person for public queries
Name 72567 0
Yoland Antill
Address 72567 0
Oncology Clinics Victoria, Cabrini Health, 183 Wattletree Rd. Malvern VIC 3144
Country 72567 0
Australia
Phone 72567 0
+ 61 3 9509 6988
Fax 72567 0
Email 72567 0
[email protected]
Contact person for scientific queries
Name 72568 0
Yoland Antill
Address 72568 0
Oncology Clinics Victoria, Cabrini Health, 183 Wattletree Rd. Malvern VIC 3144
Country 72568 0
Australia
Phone 72568 0
+ 61 3 9509 6988
Fax 72568 0
Email 72568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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