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Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients (LAAVA2)

Primary Purpose

Vulvovaginal Atrophy, Genitourinary Symptoms and Ill-Defined Conditions

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CO2 Fractional Ablative Laser
Placebo
Sponsored by
Royal North Shore Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring genitourinary symptoms of menopause, CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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)

Sites / Locations

  • Royal North Shore HospitalRecruiting
  • Sydney Adventist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CO2 Fractional Ablative Laser

Placebo

Arm Description

3 treatments approximately 4 weeks apart with vaginal/vulval laser

3 treatments approximately 4 weeks apart with "sham" laser

Outcomes

Primary Outcome Measures

Vaginal dryness
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.

Secondary Outcome Measures

Other symptoms of vulvovaginal atrophy
Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
Maturation index
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) )
Vaginal pH
Improvement in vaginal pH
Clinician Assessed Changes
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).
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
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.
Sexual Function
Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
Satisfaction with treatment assessed on a Likert Scale
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)
Safety of laser treatment (Side effects)
Side effects reported over the duration of the study will be collected descriptively

Full Information

First Posted
August 1, 2018
Last Updated
March 10, 2020
Sponsor
Royal North Shore Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03628092
Brief Title
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Acronym
LAAVA2
Official Title
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal North Shore Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero) Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy, Genitourinary Symptoms and Ill-Defined Conditions
Keywords
genitourinary symptoms of menopause, CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CO2 Fractional Ablative Laser
Arm Type
Active Comparator
Arm Description
3 treatments approximately 4 weeks apart with vaginal/vulval laser
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 treatments approximately 4 weeks apart with "sham" laser
Intervention Type
Device
Intervention Name(s)
CO2 Fractional Ablative Laser
Other Intervention Name(s)
Monalisa Touch, Lotus
Intervention Description
Vaginal / vulval laser treatment
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Sham Device
Primary Outcome Measure Information:
Title
Vaginal dryness
Description
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.
Time Frame
12 weeks after completion of treatment
Secondary Outcome Measure Information:
Title
Other symptoms of vulvovaginal atrophy
Description
Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Maturation index
Description
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) )
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Vaginal pH
Description
Improvement in vaginal pH
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Clinician Assessed Changes
Description
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).
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
Description
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.
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Sexual Function
Description
Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Satisfaction with treatment assessed on a Likert Scale
Description
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)
Time Frame
12 weeks after completion of treatment and 12 months after active treatment
Title
Safety of laser treatment (Side effects)
Description
Side effects reported over the duration of the study will be collected descriptively
Time Frame
15 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Pearson, BMed
Phone
+61402308664
Email
antonia.pearson@sydney.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Forward, MBBS MBA BSc
Phone
+61 2 9462 9657
Email
eforward.derm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Pearson, BMed
Organizational Affiliation
Royal North Shore Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Pearson, BMed FRACP
Phone
+61402308664
Email
antonia.pearson@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Emily Forward, MBBS MBA BSc
Phone
+61 2 9462 9657
Email
eforward.derm@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonia Pearson, BMed FRACP
First Name & Middle Initial & Last Name & Degree
Emily Forward, MBBS MBA Bsc
First Name & Middle Initial & Last Name & Degree
Gail Fischer, OAM FACD MD
First Name & Middle Initial & Last Name & Degree
Sally Baron-Hay, MBBS FRACP
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2074
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Stevenson
Phone
+612 9480 6283
Email
Rebecca.Stevenson@sah.org.au
First Name & Middle Initial & Last Name & Degree
Nina Singh
Phone
+612 9480 6280
Email
Nina.Singh@sah.org.au
First Name & Middle Initial & Last Name & Degree
Gavin Marx, MBBS FRACP
First Name & Middle Initial & Last Name & Degree
Andrew Booker, BMedFRANZCOG

12. IPD Sharing Statement

Learn more about this trial

Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

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