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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

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

NCT ID

NCT03628092

First Posted

August 1, 2018

Last Updated

March 10, 2020

Sponsor

Royal North Shore Hospital

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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

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

antonia.pearson@sydney.edu.au

First Name & Middle Initial & Last Name & Degree

Emily Forward, MBBS MBA BSc

Phone

+61 2 9462 9657

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

Rebecca.Stevenson@sah.org.au

First Name & Middle Initial & Last Name & Degree

Nina Singh

Phone

+612 9480 6280

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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