Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03628092




Registration number
NCT03628092
Ethics application status
Date submitted
1/08/2018
Date registered
14/08/2018
Date last updated
12/03/2020

Titles & IDs
Public title
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Scientific title
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Secondary ID [1] 0 0
LAAVA2
Universal Trial Number (UTN)
Trial acronym
LAAVA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvovaginal Atrophy 0 0
Genitourinary Symptoms and Ill-Defined Conditions 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CO2 Fractional Ablative Laser
Treatment: Devices - Placebo

Active Comparator: CO2 Fractional Ablative Laser - 3 treatments approximately 4 weeks apart with vaginal/vulval laser

Placebo Comparator: Placebo - 3 treatments approximately 4 weeks apart with "sham" laser


Treatment: Devices: CO2 Fractional Ablative Laser
Vaginal / vulval laser treatment

Treatment: Devices: Placebo
Sham Device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vaginal dryness
Timepoint [1] 0 0
12 weeks after completion of treatment
Secondary outcome [1] 0 0
Other symptoms of vulvovaginal atrophy
Timepoint [1] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [2] 0 0
Maturation index
Timepoint [2] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [3] 0 0
Vaginal pH
Timepoint [3] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [4] 0 0
Clinician Assessed Changes
Timepoint [4] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [5] 0 0
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
Timepoint [5] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [6] 0 0
Sexual Function
Timepoint [6] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [7] 0 0
Satisfaction with treatment assessed on a Likert Scale
Timepoint [7] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [8] 0 0
Safety of laser treatment (Side effects)
Timepoint [8] 0 0
15 months

Eligibility
Key inclusion criteria
- Women with a history of early breast cancer >18 years of age

- At baseline patients must have at least one of five symptoms rated at =5 on a 10cm VAS
scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.

- Three groups of patients will qualify:

- Treatment induced premature menopause =45 years of age (eg secondary to chemotherapy
or oophorectomy) for >6 months

- Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or
an aromatase inhibitor

- Postmenopausal women on tamoxifen or an aromatase inhibitor

- Willingness to give written informed consent and willingness to comply with the study

- Up to date pap test / HPV (human papillomavirus) testing
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical contraindication to the use of fractional ablative CO2 laser

- Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment

- Use of vaginal lubricants or moisturisers 14 days prior to the study treatment

- Active or recent genitourinary infections (<30 days)

- Genital prolapse (grade III)

- Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus,
lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval
dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial
neoplasia, genital warts)

- Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2074 - Wahroonga

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03628092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antonia Pearson, BMed
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Antonia Pearson, BMed
Address 0 0
Country 0 0
Phone 0 0
+61402308664
Fax 0 0
Email 0 0
antonia.pearson@sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03628092