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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Assessment method [1] 0 0
Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible.
Timepoint [1] 0 0
12 weeks after completion of treatment
Secondary outcome [1] 0 0
Other symptoms of vulvovaginal atrophy
Assessment method [1] 0 0
Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
Timepoint [1] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [2] 0 0
Maturation index
Assessment method [2] 0 0
Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture) )
Timepoint [2] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [3] 0 0
Vaginal pH
Assessment method [3] 0 0
Improvement in 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
Assessment method [4] 0 0
Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours).
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
Assessment method [5] 0 0
Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life.
Timepoint [5] 0 0
12 weeks after completion of treatment and 12 months after active treatment
Secondary outcome [6] 0 0
Sexual Function
Assessment method [6] 0 0
Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
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
Assessment method [7] 0 0
Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree)
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)
Assessment method [8] 0 0
Side effects reported over the duration of the study will be collected descriptively
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
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03628092